MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO PFR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Erosion (1750); Purulent Discharge (1812); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Hernia (2240); Prolapse (2475); Sleep Dysfunction (2517); Fibrosis (3167); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, removal date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.This event was reported by the patient's legal representation.The mesh removal was performed by: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold device was implanted in the patient on an unknown date.On (b)(6) 2018, patient underwent removal of vaginal eroded mesh, vaginal paravaginal repair with xenform bovine deraml graft implantation, vaginal uterine suspension, cervical biopsy, vaginal colpopexy and cystoscopy prcedures.Reportedly, the patient had a prolapse of the anterior wall and the uterus, and a large central and proximal erosion.

Event Description

It was reported to boston scientific corporation that an uphold device was implanted in the patient on an unknown date.On (b)(6) 2018, patient underwent removal of vaginal eroded mesh, vaginal paravaginal repair with xenform bovine dermal graft implantation, vaginal uterine suspension, cervical biopsy, vaginal colpopexy and cystoscopy procedures.Reportedly, the patient had a prolapse of the anterior wall and the uterus, and a large central and proximal erosion.The patient was implanted with either an uphold or a pinnacle prolapse repair mesh device as well as an obtryx system for the treatment of pelvic organ prolapse (pop) and stress urinary incontinence (sui) on (b)(6) 2011.The implant procedure was performed without intraoperative complications.On (b)(6) 2018, with surgical indications including pelvic pain and mesh eroding into her vagina.The patient underwent surgery to revise and partially remove the mesh implant.On (b)(6) 2019, after experiencing pelvic pain, bleeding and incontinence, the patient sought consult and it was noted by the physician that an additional exposed mesh in multiple areas was seen and the physician recommended an additional surgery to attempt to remove the remaining mesh.However, the physician noted that it may not be possible to remove all of the mesh from inside the patient.As a result of having the mesh implanted in the patient, she has experienced significant mental and physical pain and suffering, has sustained permanent injury and permanent and substantial physical deformity, has undergone and likely will continue to undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2018, removal date, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The mesh removal was performed by: (b)(6).Block h6: patient codes e2006 and e2333, and impact code f19, captures the reportable event vaginal erosion and vaginal prolapse and uterine descent, and additional surgery.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure 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 g1 (mfr site email), and g2 have been corrected.Blocks b5, e1, h6 and h10 have been updated based on the additional information received on february 13, 2023.Block h6: patient code e2330 captures the reportable event of pain.Patient code e2006 captures the reportable event of erosion.Patient code e0506 captures the reportable event of hemorrhage.Patient code e0206 captures the reportable event of unspecified mental, emotional or behavioral problem.Impact code f1905 captures the reportable event of revision procedure.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.

Manufacturer Narrative

Blocks a1, a4, b5, b6, b7, and h6 patient codes, impact codes, and device codes have been updated based on the additional information received on october 17, 2023.Block b3 date of event: date of event was approximated to november 1, 2018, removal date, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the device manufacture date and expiration date is unknown.Block e1: this event was reported by the patient's legal representation.The mesh removal was performed by: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - extrusion; e2330 - pain; e0506 - hemorrhage; e0206 - unspecified mental, emotional or behavioral problem; e1310: infection, urinary tract; e1304: urinary urgency; e232401: incontinence, fecal; e2015: atrophy; e2319: hernia; e2326: inflammation; e1007: constipation - constipation with laxatives; e2313: fibrosis; e1405: dyspareunia - interested in becoming sexually active.Imdrf impact code f1903 captures the reportable event of mesh removal.Block 11: impact code f1905: device revision/replacement has been updated to f1903: device explantation as it was reported that the device was removed.

Event Description

Note: this manufacturer report pertains to one of the two devices implanted during the same procedure.Refer to manufacturer report number 3005099803-2023-01044 for obtryx system device.It was reported to boston scientific corporation that an uphold device was implanted in the patient on an unknown date.On (b)(6) 2018, patient underwent removal of vaginal eroded mesh, vaginal paravaginal repair with xenform bovine dermal graft implantation, vaginal uterine suspension, cervical biopsy, vaginal colpopexy and cystoscopy procedures.Reportedly, the patient had a prolapse of the anterior wall and the uterus, and a large central and proximal erosion.Additional information received on february 13, 2023: the patient was implanted with either an uphold or a pinnacle prolapse repair mesh device as well as an obtryx system for the treatment of pelvic organ prolapse (pop) and stress urinary incontinence (sui) on (b)(6) 2011.The implant procedure was performed without intraoperative complications.On (b)(6) 2018, with surgical indications including pelvic pain and mesh eroding into her vagina.The patient underwent surgery to revise and partially remove the mesh implant.On (b)(6) 2019, after experiencing pelvic pain, bleeding and incontinence, the patient sought consult and it was noted by the physician that an additional exposed mesh in multiple areas was seen and the physician recommended an additional surgery to attempt to remove the remaining mesh.However, the physician noted that it may not be possible to remove all of the mesh from inside the patient.As a result of having the mesh implanted in the patient, she has experienced significant mental and physical pain and suffering, has sustained permanent injury and permanent and substantial physical deformity, has undergone and likely will continue to undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.Additional information received on october 17, 2023: on (b)(6) 2018, it was stated that on (b)(6) 2018 the patient had difficulty sleeping, abnormal vaginal bleeding and recurrent urinary tract infection.Per history of present illness, patient had a history of recurrent uti and is status post sling and cystocele repair with vaginal colpopexy/sacrospinous fixation using mesh in 2011.She presented to the clinic for a cystoscopy.She was informed about this by her gynecologist, that her mesh is out of place during the time of her pap smear.She describes an intermittent pinching sensation in her pelvis.She notes she has been having intermittent urge incontinence.She denies any dysuria, gross hematuria, and any stress incontinence.Cystoscopy was performed showing normal urethra and bladder.Patient tolerated the procedure well without complications and left the office in good condition.Assessment/plan: regarding urinary tract infection, benign cystoscopic findings noted.Bactrim was given for prophylaxis.The patient was counseled to return to the clinic if she becomes symptomatic so a urinalysis and urine culture can be completed.For microscopic hematuria, urinalysis reveals moderate rbcs and is negative for infection.Differential diagnosis was reviewed with the patient including the benign and malignant entities.A ct urogram will be obtained to further assess this, and the patient will be contacted with the results.In light of her benign cystoscopy, and being a low-risk patient, no further evaluation will be warranted if her ct urogram is benign.The patient was counseled to return to the clinic if she has any episodes of gross hematuria for further evaluation.Regarding prolapse of female genital organs, further treatment was outlined in the form of removal and replacement of her mesh.The patient was prescribed with fluconazole, ibu (ibuprofen), levothyroxine, methocarbamol, nitrofurantoin monohydrate/macrocrystals, and tizanidine.On (b)(6) 2018, pathology results reported vaginal mucosa with chronic inflammation and embedded surgical mesh material.In a clinical note of february 25, 2020, the patient's pelvic exam on (b)(6) 2018 demonstrated eroded central portion of folded mesh (mid anterior wall to proximal) and grade 2+ cystocele.She underwent vaginal eroded mesh removal (uphold mesh device).Pathology was negative for any malignancy.She was having urinary frequency and urgency with incontinence.She was instructed on daily kegel exercises and restarting vaginal estrogen cream.She was having fecal incontinence and incontinence with a full bladder and was referred to pelvic floor physical therapy.At her last visit on (b)(6) 2019 she felt as if she was having mesh erosion in her vagina.Pelvic exam revealed exposed mesh to the left side of midline distally and proximally, firmness and possible mesh band felt at proximal right anterior edge with thinning of vaginal mucosa.She was to schedule excision of her mesh.She returns today for follow up of her mesh erosion.She has not had any vaginal bleeding or discharge since her last visit.She has rare urge incontinence approximately once a month.She states this typically happens when she wakes too long to void.She denies any hematuria, dysuria, or urinary tract infections.She has not been using vaginal estrogen cream.Patient is interested in becoming sexually active.She has a colonoscopy scheduled this year.Assessment and plan included disorders of urogenital prostheses or implants: unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter.Atrophic vaginitis: postmenopausal atrophic vaginitis, prescribed vaginal cream.Urinary incontinence of urine: urge incontinence.Herniation of rectum into vagina: rectocele.Cystocele: unspecified.The patient was counseled on only treating symptomatic infections.Excision of vaginal mesh was discussed with patient; this may need to be performed if she is interested in becoming sexually active.Advised to restart vaginal estrogen three times a week for atrophy and prevent infections.Follow up for urge incontinence and follow up appointment in six months to reassess symptoms.At her last visit on (b)(6) 2019, she noted having a small amount of blood discharge after using the applicator to apply the estrogen cream.During her visit today, she reported she occasionally feels the mesh when she walks.She is no longer wearing a pad for urinary leaking and states she leaks less while she is at work.She uses the vaginal estrogen cream once a day for 2 weeks.Her leg pain has resolved since her last surgery in (b)(6) 2018.She denies bloody vaginal discharge, hematuria, dysuria, or urinary tract infections.In an assessment, her stress incontinence has improved.At (b)(6) 2022 appointment, the patient noticed a strange vaginal odor.She had an intermittent urine stream with decreased sensation.She had constipation and is taking laxatives - following with gastrointestinal.She denied any utis.She was still having intermittent right leg pain starting at the pelvis and radiating down.On (b)(6) 2022, vaginal estrogen cream improved her urinary symptoms.She stated the cream turns pink after being inserted and denied any discharge.On (b)(6) 2023, she returned for follow up of her vaginal mesh erosion and urge incontinence status post vaginal mesh removal on (b)(6) 2023, pathology with fibromuscular tissue with embedded mesh and chronic inflammation.She continued using vaginal estrogen cream three times a week.She had constipation and had not taken anything to manage constipation.In an assessment and plan, she was advised to take miralax daily or fiber and increased water intake to manage constipation; and refill and continue vaginal estrogen cream three times per week for atrophy.The patient was scheduled for a follow up appointment in one year.

• Brand Name: CAPIO PFR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112-1242 ; 5086834015
• MDR Report Key: 11419231
• MDR Text Key: 238406567
• Report Number: 3005099803-2021-00908
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 80 KG