MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068502110

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Material Split, Cut or Torn (4008)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Itching Sensation (1943); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Anxiety (2328); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/23/2020

Event Type Injury

Event Description

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020, procedure date, as no event date was reported.(b)(4) captures the reportable event of unknown injury.(b)(4) has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block b3 date of event: date of event was approximated to july 23, 2020, procedure date, as no event date was reported.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block g2 has been corrected.Blocks a2, b5, b7, h6, and h10 have been updated based on the additional information received on november 3, 2022.Block h6: imdrf patient code e2330 was utilized to capture the reportable events of "slightly tender there," "pelvic pain," "tenderness on left and possibly right sulcus," "the patient felt pinchy," "she was in so much pain from the internal exam," and "tender at the sites of mesh exposure." imdrf patient code e2006 was utilized to capture the reportable events of "physician can feel the sling near but not through the vaginal epithelium in sulcus on the left," "patient had mesh exposure," "she can feel mesh with finger," and "mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus." imdrf patient code e1310 was utilized to capture the reportable event of "the patient was experiencing urinary tract infection (uti)." imdrf patient code e1405 was utilized to capture the reportable event of "tenderness and concerns about sexual function." imdrf patient code e2015 was utilized to capture the reportable event of "atrophic vaginitis." imdrf patient code e2401 was utilized to capture the reportable event of "muscle disorder (pelvic floor dysfunction)." imdrf patient code e020201 was utilized to capture the reportable event of "anxiety." imdrf patient code e0506 was utilized to capture the reportable event of "abnormal vaginal bleeding." imdrf patient code e2326 was utilized to capture the reportable event of "vaginitis." imdrf patient code e1605 was utilized to capture the reportable event of "pelvic floor muscle (pfm) were very tense," and "pfm were also extremely tense." imdrf impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, procedure date, as no event date was reported.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks a2, b5, b7, h6, and h10 have been updated based on the additional information received on november 3, 2022.Block h6: imdrf patient code e2330 was utilized to capture the reportable events of "slightly tender there," "pelvic pain," "tenderness on left and possibly right sulcus," "the patient felt pinchy," "she was in so much pain from the internal exam," and "tender at the sites of mesh exposure." imdrf patient code e2006 was utilized to capture the reportable events of "physician can feel the sling near but not through the vaginal epithelium in sulcus on the left," "patient had mesh exposure," "she can feel mesh with finger," and "mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus." imdrf patient code e1310 was utilized to capture the reportable event of "the patient was experiencing urinary tract infection (uti)." imdrf patient code e1405 was utilized to capture the reportable event of "tenderness and concerns about sexual function." imdrf patient code e2015 was utilized to capture the reportable event of "atrophic vaginitis." imdrf patient code e2401 was utilized to capture the reportable event of "muscle disorder (pelvic floor dysfunction)." imdrf patient code e020201 was utilized to capture the reportable event of "anxiety." imdrf patient code e0506 was utilized to capture the reportable event of "abnormal vaginal bleeding." imdrf patient code e2326 was utilized to capture the reportable event of "vaginitis." imdrf patient code e1605 was utilized to capture the reportable event of "pelvic floor muscle (pfm) were very tense," and "pfm were also extremely tense." imdrf impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block a1, b5, h6 and h10 have been corrected based on the medical safety review received on december 14, 2022.Blocks b5, d6b, h6 and h10 have been updated based on the additional information received on january 4, 2023.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Phone number: (b)(6).Revision surgery performed by: (b)(6).Block h6: patient code e2330 was utilized to capture the reportable events of "slightly tender there," "pelvic pain," "tenderness on left and possibly right sulcus," "the patient felt pinchy," "she was in so much pain from the internal exam," and "tender at the sites of mesh exposure." patient code e2006 was utilized to capture the reportable events of "physician can feel the sling near but not through the vaginal epithelium in sulcus on the left," "patient had mesh exposure," "she can feel mesh with finger," and "mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus." patient code e1310 was utilized to capture the reportable event of "the patient was experiencing urinary tract infection (uti)." patient code e2326 was utilized to capture the reportable event of "vaginitis." patient code e1405 was utilized to capture the reportable event of "dyspareunia." patient code e2015 was utilized to capture the reportable event of "atrophic vaginitis." patient code e2401 was utilized to capture the reportable event of "muscle disorder (pelvic floor dysfunction)." patient code e1605 was utilized to capture the reportable event of "pelvic floor muscle (pfm) were very tense," and "pfm were also extremely tense." patient code e020201 was utilized to capture the reportable event of "anxiety." patient code e0506 was utilized to capture the reportable event of "abnormal vaginal bleeding." patient code e1715 was utilized to capture the reportable event of "scar tissue in this area." impact code f1905: device revision or replacement was utilized to capture the event of "vaginal sling revision." impact code f1903: device explantation was utilized to capture the event of "the complete mesh was removed." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022: the procedure performed on july 23, 2020 were retropubic mid urethral sling (advantage fit) placement, and cystoscopy procedures to treat a patient with stress urinary incontinence.Findings include on examination under anesthesia, the patient had stage ii prolapse consistent with what the physician saw in the office.Cystoscopy revealed a normal bladder with patent ureters bilaterally and a normal urethra.The bladder remained intact throughout, and the sling could be seen rolling appropriately behind the urothelium.Patient was taken to recovery room in stable condition, having tolerated the procedure well.Patient's condition at conclusion of procedure was stable.The patient was discharged home and was instructed to do activities as tolerated but avoid heavy lifting, no driving on pain meds, and nothing in the vagina for 6 weeks except vaginal estrogen cream.The patient was instructed for follow up in one to six weeks.On (b)(6) 2020, the patient was seen and examined.The patient was doing well and symptoms resolved.The physician can feel the sling near but not through the vaginal epithelium in sulcus on the left.The patient was slightly tender there.The physician thought it will improve with time as she continued to heal.They discussed that the only concern with mesh exposure was if it bothered her or her partner.She was scheduled for follow up in 6 weeks to see if her symptoms have improved.She was prescribed to use vaginal estrogen nightly for several weeks and then go back to the 3 times weekly.In the physician's assessment the patient was experiencing urinary tract infection (uti), anxiety, atrophic vaginitis, mixed urinary incontinence, muscle disorder (pelvic floor dysfunction) and prolapse of vaginal vault after hysterectomy.Upon examination, it was noted that the patient had abnormal vaginal bleeding and pelvic pain.On (b)(6) 2020, the patient was seen and examined.The physician assessed unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter as new.The patient had mesh exposure and tenderness on left and possibly right sulcus.They had a long discussion regarding options for management.The patient was very happy with her continence outcome and has been doing very nicely from that perspective.She was concerned about capacity for sexual function in the future with mesh exposed in vagina.They discussed that mesh exposure was not dangerous per se and that if she were asymptomatic, she could manage expectantly.With her tenderness and concerns about sexual function, they agreed that it made most sense to treat the exposure.The exposure was refractory to conservative treatment with estrogen, so surgical management would be the next step.Since she has possible exposure on both sides, they discussed several options.They could remove entire vaginal portion of sling, allow her to heal three months, then repeat sling if necessary; they could remove vaginal portion of sling and do pubovaginal sling at same time; they could remove only a portion of the sling and see how she did with the other side and her continence outcome.With her concerns about timing, she was considering waiting until after november to have the entire vaginal portion removed.She would then anticipate needing retreatment for incontinence in about february.The assessed muscle disorder - pelvic floor dysfunction as unchanged - her pfm were very tense and likely responsible for some of her pain.Discussed that pt may be required to help improve the pain and tension.Upon examination, the patient has been doing the cream about 6 days per week, her breasts felt big and itchy, and the patient was gaining weight.She also felt nauseated.The patient felt better after she stopped 4-5 days.Was doing vagifem.Tissues were feeling more plump.She can feel mesh with finger, the patient felt pinchy.When she left after her previous visit on (b)(6) 2020, she was in so much pain from the internal exam.She could not run for a week.No blood nor discharge was noted.The patient just felt pain.Upon vaginal examination, a well-healed incision was noted on the patient's external genitalia.There was mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus.The surrounding epithelium was well-estrogenized, she was tender at the sites of mesh exposure; pfm were also extremely tense and tender.Additional information received on january 4, 2023: on (b)(6) 2020, the patient underwent a vaginal sling revision, urethrolysis, (b)(6) laparoscopic tvt mesh removal, laparoscopic burch, suprapubic catheter placement, cystoscopy and exparel injection procedures.Preoperative and post operative diagnosis include, right lower quadrant pain, left lower quadrant pain, vaginal mesh extrusion, pelvic pain, dyspareunia, stress urinary incontinence and mesh extrusion through the vagina.Upon examination under anesthesia, they noticed that the patient had vaginal mesh extrusion through the vaginal epithelium on the patient's left side of the urethra and a cording and tightness of the mesh on both the right and left side.In the office, examination revealed vaginal pain at the periurethral area as well as the left and right pubic area, and the left and right lower quadrants.After the patient was prepped and draped in the usual sterile fashion, and after she received an adequate amount of anesthesia, turned their attention toward the vagina.Made a vertical midline skin incision, mobilized vaginal epithelium bilaterally, and then identified the sling and dissected between the sling and the urethra, cut the sling in the midline for a sling revision.At this time, they dissected the mesh all the way to the pubocervical fascia bilaterally, and then, incised and cut the mesh at its insertion point of the pubocervical fascia on each side of the urethra.At this point, urethrolysis had been performed.Due to all the scar tissue in this area, they mobilized the mesh away from the vaginal epithelium and the underlying urethra and the periurethral tissue.Because of the bleeding in this area, they made it hemostatic using sutures, and they used the sutures to elevate the suburethral area using #2-0 vicryl in a mattress fashion.At this time, they closed the vaginal epithelium with #2-0 vicryl suture, and turned their attention towards the abdomen and began with their laparoscopic approach.At this time, they did an open laparoscopy, 3 of the ports were placed under direct visualization.Mobilized the bowel of the cul-de-sac, retrograde filled the bladder, and then entered the space of retzius between the obliterated umbilical ligaments, 2 cm anterior to the vesicoperitoneal reflection.They found their way into the space of retzius, identified their insertion points, i.E., of the mesh into the anterior abdominal wall.They actually mobilized it off the cooper's ligament first, forced their way anteriorly to the anterior abdominal wall cold, and put tension on the arms going into the anterior abdominal wall, until they actually cut the mesh out of the anterior abdominal wall bilaterally.There was no mesh left in the anterior abdominal wall.They then dissected all the way down to the pubocervical fascia and cut the mesh at the pubocervical fascia.At this time, the complete mesh was removed, and they did a laparoscopic burch procedure.Using cv2 gore-tex suture in a figure-of-eight fashion, 2 sutures were placed on each side of the urethra through the pubocervical fascia in a figure-of-eight fashion, one at the mid urethra, one at urethrovesical junction up to the ipsilateral cooper's ligament.This elevated and made a hammock for the suburethral area.They made the area hemostatic, placed some floseal, and closed the vesicoperitoneal reflection with #0 monocryl suture.At this point, they did a cystoscopy.No evidence of exudate, diverticulum or malignancy.No evidence of needle penetration or trauma to bladder or urethral mucosa.Bilateral ureteral patency was confirmed.At this time, they did a suprapubic catheter placement, both with a cystoscopic and laparoscopic vision.They watched it enter the dome of the bladder.Once they did, they pulled out the introducer, removed their guidewire first, and then blew up the foley balloon in the dome of the bladder, retracted on the foley bulb into the dome of the bladder and found the area was hemostatic.They closed the port sites in a normal fashion after removing their ports.Packed the patient's vagina and sent to the recovery room in stable condition.There were no patient complications reported at the conclusion of the procedure.

Manufacturer Narrative

Blocks b5, b6, b7, and h6: patient codes and device codes have been updated based on the additional information received on july 19, 2023.Block b3 date of event: date of event was approximated to july 23, 2020, procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6) at (b)(6) hospital.Phone number: (b)(6).Revision surgery performed by: dr.(b)(6) at (b)(6) hospital.Block h6: patient code e2330 was utilized to capture the reportable events of "slightly tender there," "pelvic pain," "tenderness on left and possibly right sulcus," "the patient felt pinchy," "she was in so much pain from the internal exam," and "tender at the sites of mesh exposure." patient code e2006 was utilized to capture the reportable events of "physician can feel the sling near but not through the vaginal epithelium in sulcus on the left," "patient had mesh exposure," "she can feel mesh with finger," and "mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus." patient code e1310 was utilized to capture the reportable event of "the patient was experiencing urinary tract infection (uti)." patient code e2326 was utilized to capture the reportable event of "vaginitis." patient code e1405 was utilized to capture the reportable event of "dyspareunia." patient code e2015 was utilized to capture the reportable event of "atrophic vaginitis." patient code e2401 was utilized to capture the reportable event of "muscle disorder (pelvic floor dysfunction)." patient code e1605 was utilized to capture the reportable event of "pelvic floor muscle (pfm) was very tense," and "pfm were also extremely tense." patient code e020201 was utilized to capture the reportable event of "anxiety." patient code e0506 was utilized to capture the reportable event of "abnormal vaginal bleeding." patient code e1715 was utilized to capture the reportable event of "scar tissue in this area." impact code f1905: device revision or replacement was utilized to capture the event of "vaginal sling revision." patient code e2333 captures the reportable event of bulge and pressure and rectocele that required intervention.Device code a0414 captures the reportable event of tattered mesh.Impact code f1903: device explantation was utilized to capture the event of "the complete mesh was removed.".

Event Description

It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on july 23, 2020.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on november 3, 2022: past medical history: the patient had seven total number of confirmed pregnancies and three total number of births.The patient had four spontaneous abortions.The procedure performed on (b)(6) 2020 were retropubic mid urethral sling (advantage fit) placement, and cystoscopy procedures to treat a patient with stress urinary incontinence.Findings include on examination under anesthesia, the patient had stage ii prolapse consistent with what the physician saw in the office.Cystoscopy revealed a normal bladder with patent ureters bilaterally and a normal urethra.The bladder remained intact throughout, and the sling could be seen rolling appropriately behind the urothelium.Patient was taken to recovery room in stable condition, having tolerated the procedure well.Patient's condition at conclusion of procedure was stable.The patient was discharged home and was instructed to do activities as tolerated but avoid heavy lifting, no driving on pain meds, and nothing in the vagina for 6 weeks except vaginal estrogen cream.The patient was instructed for follow up in one to six weeks.On (b)(6) 2020, the patient was seen and examined.The patient was doing well and symptoms resolved.The physician can feel the sling near but not through the vaginal epithelium in sulcus on the left.The patient was slightly tender there.The physician thought it will improve with time as she continued to heal.They discussed that the only concern with mesh exposure was if it bothered her or her partner.She was scheduled for follow up in 6 weeks to see if her symptoms have improved.She was prescribed to use vaginal estrogen nightly for several weeks and then go back to the 3 times weekly.In the physician's assessment the patient was experiencing urinary tract infection (uti), anxiety, atrophic vaginitis, mixed urinary incontinence, muscle disorder (pelvic floor dysfunction) and prolapse of vaginal vault after hysterectomy.Upon examination, it was noted that the patient had abnormal vaginal bleeding and pelvic pain.On (b)(6) 2020, the patient was seen and examined.The physician assessed unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter as new.The patient had mesh exposure and tenderness on left and possibly right sulcus.They had a long discussion regarding options for management.The patient was very happy with her continence outcome and has been doing very nicely from that perspective.She was concerned about capacity for sexual function in the future with mesh exposed in vagina.They discussed that mesh exposure was not dangerous per se and that if she were asymptomatic, she could manage expectantly.With her tenderness and concerns about sexual function, they agreed that it made most sense to treat the exposure.The exposure was refractory to conservative treatment with estrogen, so surgical management would be the next step.Since she has possible exposure on both sides, they discussed several options.They could remove entire vaginal portion of sling, allow her to heal three months, then repeat sling if necessary; they could remove vaginal portion of sling and do pubovaginal sling at same time; they could remove only a portion of the sling and see how she did with the other side and her continence outcome.With her concerns about timing, she was considering waiting until after november to have the entire vaginal portion removed.She would then anticipate needing retreatment for incontinence in about february.The assessed muscle disorder - pelvic floor dysfunction as unchanged - her pfm were very tense and likely responsible for some of her pain.Discussed that pt may be required to help improve the pain and tension.Upon examination, the patient has been doing the cream about 6 days per week, her breasts felt big and itchy, and the patient was gaining weight.She also felt nauseated.The patient felt better after she stopped 4-5 days.Was doing vagifem.Tissues were feeling more plump.She can feel mesh with finger, the patient felt pinchy.When she left after her previous visit on (b)(6) 2020, she was in so much pain from the internal exam.She could not run for a week.No blood nor discharge was noted.The patient just felt pain.Upon vaginal examination, a well-healed incision was noted on the patient's external genitalia.There was mesh exposed in the left sulcus and exposed vs very superficial in the right sulcus.The surrounding epithelium was well-estrogenized, she was tender at the sites of mesh exposure; pfm were also extremely tense and tender.Additional information received on january 4, 2023: on (b)(6) 2020, the patient underwent a vaginal sling revision, urethrolysis, kelly plication, laparoscopic tvt mesh removal, laparoscopic burch, suprapubic catheter placement, cystoscopy and exparel injection procedures.Preoperative and post operative diagnosis include, right lower quadrant pain, left lower quadrant pain, vaginal mesh extrusion, pelvic pain, dyspareunia, stress urinary incontinence and mesh extrusion through the vagina.Upon examination under anesthesia, they noticed that the patient had vaginal mesh extrusion through the vaginal epithelium on the patient's left side of the urethra and a cording and tightness of the mesh on both the right and left side.In the office, examination revealed vaginal pain at the periurethral area as well as the left and right pubic area, and the left and right lower quadrants.After the patient was prepped and draped in the usual sterile fashion, and after she received an adequate amount of anesthesia, turned their attention toward the vagina.Made a vertical midline skin incision, mobilized vaginal epithelium bilaterally, and then identified the sling and dissected between the sling and the urethra, cut the sling in the midline for a sling revision.At this time, they dissected the mesh all the way to the pubocervical fascia bilaterally, and then, incised and cut the mesh at its insertion point of the pubocervical fascia on each side of the urethra.At this point, urethrolysis had been performed.Due to all the scar tissue in this area, they mobilized the mesh away from the vaginal epithelium and the underlying urethra and the periurethral tissue.Because of the bleeding in this area, they made it hemostatic using sutures, and they used the sutures to elevate the suburethral area using #2-0 vicryl in a mattress fashion.At this time, they closed the vaginal epithelium with #2-0 vicryl suture, and turned their attention towards the abdomen and began with their laparoscopic approach.At this time, they did an open laparoscopy, 3 of the ports were placed under direct visualization.Mobilized the bowel of the cul-de-sac, retrograde filled the bladder, and then entered the space of retzius between the obliterated umbilical ligaments, 2 cm anterior to the vesicoperitoneal reflection.They found their way into the space of retzius, identified their insertion points, i.E., of the mesh into the anterior abdominal wall.They actually mobilized it off the cooper's ligament first, forced their way anteriorly to the anterior abdominal wall cold, and put tension on the arms going into the anterior abdominal wall, until they actually cut the mesh out of the anterior abdominal wall bilaterally.There was no mesh left in the anterior abdominal wall.They then dissected all the way down to the pubocervical fascia and cut the mesh at the pubocervical fascia.At this time, the complete mesh was removed, and they did a laparoscopic burch procedure.Using cv2 gore-tex suture in a figure-of-eight fashion, 2 sutures were placed on each side of the urethra through the pubocervical fascia in a figure-of-eight fashion, one at the mid urethra, one at urethrovesical junction up to the ipsilateral cooper's ligament.This elevated and made a hammock for the suburethral area.They made the area hemostatic, placed some floseal, and closed the vesicoperitoneal reflection with #0 monocryl suture.At this point, they did a cystoscopy.No evidence of exudate, diverticulum or malignancy.No evidence of needle penetration or trauma to bladder or urethral mucosa.Bilateral ureteral patency was confirmed.At this time, they did a suprapubic catheter placement, both with a cystoscopic and laparoscopic vision.They watched it enter the dome of the bladder.Once they did, they pulled out the introducer, removed their guidewire first, and then blew up the foley balloon in the dome of the bladder, retracted on the foley bulb into the dome of the bladder and found the area was hemostatic.They closed the port sites in a normal fashion after removing their ports.Packed the patient's vagina and sent to the recovery room in stable condition.There were no patient complications reported at the conclusion of the procedure.Additional information received on july 19, 2023: the patient stated that since the implant surgery, it has fixed the incontinence.However, after about a week, the patient felt something snap and buckled.Final pathologic diagnosis included fibroconnective tissue with focal chronic inflammation.It consists of multiple tattered portions of tan mesh with attached soft tissue.In an office visit on (b)(6) 2021, the patient had symptoms of bulge and pressure, and also some issues with bowel evacuation.Rectocele repair was recommended.Her pain has dramatically improved after the sling removal surgery; however, she would like to get her rectocele repaired.Assessment: vaginal enterocele, rectocele.Plan: posterior repair with possible dermal graft, ic vaginal vault suspension.

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Brand Name

ADVANTAGE FIT SYSTEM

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

BOSTON SCIENTIFIC CORPORATION

780 brookside drive

spencer IN 47460

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

15359776

MDR Text Key

299286659

Report Number

3005099803-2022-04925

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729772880

UDI-Public

08714729772880

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K020110

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

09/06/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

07/14/2022

Device Model Number

M0068502110

Device Catalogue Number

850-211

Device Lot Number

0024106638

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

07/19/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

07/15/2019

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other;

Patient Age

56 YR

Patient Sex

Female

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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