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

Model Number M0068502000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Granuloma (1876); Pain (1994); Perforation (2001); Urinary Retention (2119); Hot Flashes/Flushes (2153); Discomfort (2330); Obstruction/Occlusion (2422); Constipation (3274); Insufficient Information (4580)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the sling placement.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The excised mesh 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

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a tension-free vaginal tape (tvt) advantage sling placement procedure performed on (b)(6) 2018 to treat genuine stress incontinence.Post-procedure, the patient was not able to void and was given with a foley catheter.On (b)(6) 2018, during her post-operative visit, the foley catheter was removed, and had no other problems.On (b)(6) 2018, during her second post-operative visit for her genuine stress incontinence, the patient still experienced shooting pain to her legs like when she was pregnant.She had no difficulty in voiding.Furthermore, she had not resumed her exercises, but she was able to go back to work and with other activities.Also, her bowel movement was okay but sometimes it was painful.On (b)(6) 2019, the patient was diagnosed with dermoid cyst.She was presented for her annual exam with a good bladder control but ever since, she has had daily discomfort.The patient had a snagging feel on her left side which comes and goes and noted it the most when her bladder was full.However, she was still aware when she was empty.The patient felt like there was a baseline for her discomfort with exacerbations.She felt no pain with intercourse but only felt a little pain after.It was also painful for the patient during working out, however, it would settle.Reportedly, the patient observed that her discomfort was most felt at the left lower quadrant (llq), well above the location of the sling.On (b)(6) 2019, the patient had a surgery consultation for her left ovary dermoid cyst.The patient had an ultrasound which showed a left ovarian cyst and on magnetic resonance imaging (mri), it showed 2 cysts consistent with dermoid.On (b)(6) 2019, the patient had a left ovarian dermoid cyst, abdominal, and pelvic adhesions.She had undergone through right and left fallopian tube, left ovary, left salpingo-oophorectomy, and right salpingectomy.Post-procedure, the findings showed a top normal size uterus sounded to 9cm with a small subserosal fibroid noted, a normal right tube and ovary.Additionally, an enlarged multiloculated left ovary was found at the completion of the case and noted to be a dermoid and adhesions of the descending colon to the ovary and infundibulopelvic ligament as well as mild adhesions of the ovary to the bowel.On (b)(6) 2019, the patient had a postoperative visit for her dermoid cyst left ovary.It was post-procedure day 20 with no surgical complications.Also, the pathology results showed a mature cystic, and mature teratoma.The patient experienced pain after eating and had constipation in which her stools were little hard.The patient had an appointment on (b)(6) 2019 for her perimenopausal symptoms that were felt since the surgery.The patient mentioned that her last cycle was on (b)(6) 2019, and she started to have hot flashes as well.She had a laparoscopic left oophorectomy in (b)(6).The patient did have some issues with feeling hotter prior to the surgery but felt that it had worsened since the surgery, especially this month and with her missing cycle.The patient had a colonoscopy procedure on (b)(6) 2020, which revealed a questionable metal mesh at 35cm and occluded the lumen.On (b)(6) 2020, the patient's computed tomography (ct) scan abdominal/pelvic demonstrated a tubular foreign body measuring approximately 4 to 5cm in length in the sigmoid colon.Currently, the patient has small bowel movement daily, and she felt somewhat constipated.She had not taken laxatives, and she rarely had seen a bright red blood per rectum.Moreover, there was no mucus or pus per rectum, and she had no pain felt with bowel movements.The patient has not had a significant weight loss and her appetite was good.However, she felt llq pain that radiates.It had improved somewhat since her ovarian dermoid was removed, but it was not completely resolved.The patient had an mri of the pelvis only done in (b)(6) 2019, but that was prior the ovarian cystectomy, and did not had taken the image of the abdomen.The mesh/stent could not be seen there.On (b)(6) 2020, the patient was diagnosed with partial intestinal obstruction with unspecified cause and had a foreign body in her colon.On (b)(6) 2020, the patient had mesh invading the sigmoid colon and she underwent a colonoscopy flexible with biopsy procedure.It was found out that there were granuloma and plastic woven foreign body encountered -60cm into colonoscopy.In addition, the area was tattooed and tortuous colon.On (b)(6) 2020, the patient had unspecified abdominal pain and sigmoid obstruction with mesh erosion into the sigmoid colon.Furthermore, the patient had undergone a laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy with foreign body excision, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedure.Patient tolerated the procedure well and after a short stay in pacu, she was transferred to the surgical floor in stable condition.Pain medications were transitioned from iv to oral as tolerated.As the patient regained bowel function, her diet was advanced to regular which the patient tolerated well.Subsequently, the patient was discharged.On (b)(6) 2020, post-operation day 1, the patient felt well, and her pain was well-controlled on ivp dilaudid with standing tylenol.Also, she had no bowel function, and there was tenderness felt on her abdomen.On (b)(6) 2020, post-operation day 2, the patient was on oral pain medications, still with standing tylenol.She felt well, and pain was well-controlled.

Manufacturer Narrative

Correction to block b5 and h6 - to report relevant information surrounding the event that was not included in the previous report but was provided in the medical records.Also, patient ar code e2114 for perforation was added to capture this event.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the sling placement.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The surgeon is: dr.(b)(6) (implant physician).(b)(6).Telephone no.(b)(6).Fax no.(b)(6).(b)(6).Telephone no.(b)(6).Dr.(b)(6) (mesh excision physician).(b)(6).Block h6: patient codes e2006, e2101, e1309, e2328, e2317, e2330, e1002, e2114 and e2401 capture the reportable events of sigmoid colon mesh erosion, abdominal, and pelvic adhesions, urinary retention, partial intestinal obstruction, granuloma, pain, left lower quadrant pain, perforation and left ovarian dermoid cyst.Impact codes f1903, and f1901 captures the reportable events of foreign body excision, right and left fallopian tube, left ovary, left salpingo-oophorectomy, right salpingectomy, laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedures.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh 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

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a tension-free vaginal tape (tvt) advantage sling placement procedure performed on (b)(6) 2018 to treat genuine stress incontinence.Post-procedure, the patient was not able to void and was given with a foley catheter.On (b)(6) 2018, during her post-operative visit, the foley catheter was removed, and had no other problems.On (b)(6) 2018, during her second post-operative visit for her genuine stress incontinence, the patient still experienced shooting pain to her legs like when she was pregnant.She had no difficulty in voiding.Furthermore, she had not resumed her exercises, but she was able to go back to work and with other activities.Also, her bowel movement was okay but sometimes it was painful.On (b)(6) 2019, the patient was diagnosed with dermoid cyst.She was presented for her annual exam with a good bladder control but ever since, she has had daily discomfort.The patient had a snagging feel on her left side which comes and goes and noted it the most when her bladder was full.However, she was still aware when she was empty.The patient felt like there was a baseline for her discomfort with exacerbations.She felt no pain with intercourse but only felt a little pain after.It was also painful for the patient during working out, however, it would settle.Reportedly, the patient observed that her discomfort was most felt at the left lower quadrant (llq), well above the location of the sling.On (b)(6) 2019, the patient had a surgery consultation for her left ovary dermoid cyst.The patient had an ultrasound which showed a left ovarian cyst and on magnetic resonance imaging (mri), it showed 2 cysts consistent with dermoid.On (b)(6) 2019, the patient had a left ovarian dermoid cyst, abdominal, and pelvic adhesions.She had undergone through right and left fallopian tube, left ovary, left salpingo-oophorectomy, and right salpingectomy.Post-procedure, the findings showed a top normal size uterus sounded to 9cm with a small subserosal fibroid noted, a normal right tube and ovary.Additionally, an enlarged multiloculated left ovary was found at the completion of the case and noted to be a dermoid and adhesions of the descending colon to the ovary and infundibulopelvic ligament as well as mild adhesions of the ovary to the bowel.On (b)(6) 2019, the patient had a postoperative visit for her dermoid cyst left ovary.It was post-procedure day 20 with no surgical complications.Also, the pathology results showed a mature cystic, and mature teratoma.The patient experienced pain after eating and had constipation in which her stools were little hard.The patient had an appointment on (b)(6) 2019 for her perimenopausal symptoms that were felt since the surgery.The patient mentioned that her last cycle was on (b)(6) 2019, and she started to have hot flashes as well.She had a laparoscopic left oophorectomy in october.The patient did have some issues with feeling hotter prior to the surgery but felt that it had worsened since the surgery, especially this month and with her missing cycle.The patient had a colonoscopy procedure on (b)(6) 2020, which revealed a questionable metal mesh at 35cm and occluded the lumen.On (b)(6) 2020, the patient's computed tomography (ct) scan abdominal/pelvic demonstrated a tubular foreign body measuring approximately 4 to 5cm in length in the sigmoid colon.Currently, the patient has small bowel movement daily, and she felt somewhat constipated.She had not taken laxatives, and she rarely had seen a bright red blood per rectum.Moreover, there was no mucus or pus per rectum, and she had no pain felt with bowel movements.The patient has not had a significant weight loss and her appetite was good.However, she felt llq pain that radiates.It had improved somewhat since her ovarian dermoid was removed, but it was not completely resolved.The patient had an mri of the pelvis only done in (b)(6) 2019, but that was prior the ovarian cystectomy, and did not had taken the image of the abdomen.The mesh/stent could not be seen there.On (b)(6) 2020, the patient was diagnosed with partial intestinal obstruction with unspecified cause and had a foreign body in her colon.On (b)(6) 2020, the patient had mesh invading the sigmoid colon and she underwent a colonoscopy flexible with biopsy procedure.It was found out that there were granuloma and plastic woven foreign body encountered -60cm into colonoscopy.In addition, the area was tattooed and tortuous colon.On (b)(6) 2020, the patient had unspecified abdominal pain and sigmoid obstruction with mesh erosion into the sigmoid colon.Furthermore, the patient had undergone a laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy with foreign body excision, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedure.Patient tolerated the procedure well and after a short stay in pacu, she was transferred to the surgical floor in stable condition.Pain medications were transitioned from iv to oral as tolerated.As the patient regained bowel function, her diet was advanced to regular which the patient tolerated well.Subsequently, the patient was discharged.Additionally, the surgical pathology findings from the specimen showed that a 6.0 x 0.6 x 0.3 cm intraluminal foreign body was consistent with mesh within a 0.6 cm defect in the area of tattoo ink.Therefore, the problem was probable consistent with perforation.On (b)(6) 2020, post-operation day 1, the patient felt well, and her pain was well-controlled on ivp dilaudid with standing tylenol.Also, she had no bowel function, and there was tenderness felt on her abdomen.On (b)(6) 2020, post-operation day 2, the patient was on oral pain medications, still with standing tylenol.She felt well, and pain was well-controlled.

Manufacturer Narrative

Correction to block a1: patient identifier.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the sling placement.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6) block h6: patient codes e2006, e2101, e1309, e2328, e2317, e2330, e1002, e2114 and e2401 capture the reportable events of sigmoid colon mesh erosion, abdominal, and pelvic adhesions, urinary retention, partial intestinal obstruction, granuloma, pain, left lower quadrant pain, perforation and left ovarian dermoid cyst.Impact codes f1903, and f1901 captures the reportable events of foreign body excision, right and left fallopian tube, left ovary, left salpingo-oophorectomy, right salpingectomy, laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedures.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh 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

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a tension-free vaginal tape (tvt) advantage sling placement procedure performed on (b)(6), 2018 to treat genuine stress incontinence.Post-procedure, the patient was not able to void and was given with a foley catheter.On (b)(6) 2018, during her post-operative visit, the foley catheter was removed, and had no other problems.On (b)(6), 2018, during her second post-operative visit for her genuine stress incontinence, the patient still experienced shooting pain to her legs like when she was pregnant.She had no difficulty in voiding.Furthermore, she had not resumed her exercises, but she was able to go back to work and with other activities.Also, her bowel movement was okay but sometimes it was painful.On (b)(6) 2019, the patient was diagnosed with dermoid cyst.She was presented for her annual exam with a good bladder control but ever since, she has had daily discomfort.The patient had a snagging feel on her left side which comes and goes and noted it the most when her bladder was full.However, she was still aware when she was empty.The patient felt like there was a baseline for her discomfort with exacerbations.She felt no pain with intercourse but only felt a little pain after.It was also painful for the patient during working out, however, it would settle.Reportedly, the patient observed that her discomfort was most felt at the left lower quadrant (llq), well above the location of the sling.On (b)(6), 2019, the patient had a surgery consultation for her left ovary dermoid cyst.The patient had an ultrasound which showed a left ovarian cyst and on magnetic resonance imaging (mri), it showed 2 cysts consistent with dermoid.On (b)(6) 2019, the patient had a left ovarian dermoid cyst, abdominal, and pelvic adhesions.She had undergone through right and left fallopian tube, left ovary, left salpingo-oophorectomy, and right salpingectomy.Post-procedure, the findings showed a top normal size uterus sounded to 9cm with a small subserosal fibroid noted, a normal right tube and ovary.Additionally, an enlarged multiloculated left ovary was found at the completion of the case and noted to be a dermoid and adhesions of the descending colon to the ovary and infundibulopelvic ligament as well as mild adhesions of the ovary to the bowel.On (b)(6), 2019, the patient had a postoperative visit for her dermoid cyst left ovary.It was post-procedure day 20 with no surgical complications.Also, the pathology results showed a mature cystic, and mature teratoma.The patient experienced pain after eating and had constipation in which her stools were little hard.The patient had an appointment on (b)(6), 2019 for her perimenopausal symptoms that were felt since the surgery.The patient mentioned that her last cycle was on (b)(6), 2019, and she started to have hot flashes as well.She had a laparoscopic left oophorectomy in october.The patient did have some issues with feeling hotter prior to the surgery but felt that it had worsened since the surgery, especially this month and with her missing cycle.The patient had a colonoscopy procedure on (b)(6), 2020, which revealed a questionable metal mesh at 35cm and occluded the lumen.On(b)(6), 2020, the patient's computed tomography (ct) scan abdominal/pelvic demonstrated a tubular foreign body measuring approximately 4 to 5cm in length in the sigmoid colon.Currently, the patient has small bowel movement daily, and she felt somewhat constipated.She had not taken laxatives, and she rarely had seen a bright red blood per rectum.Moreover, there was no mucus or pus per rectum, and she had no pain felt with bowel movements.The patient has not had a significant weight loss and her appetite was good.However, she felt llq pain that radiates.It had improved somewhat since her ovarian dermoid was removed, but it was not completely resolved.The patient had an mri of the pelvis only done in (b)(6) 2019, but that was prior the ovarian cystectomy, and did not had taken the image of the abdomen.The mesh/stent could not be seen there.On (b)(6), 2020, the patient was diagnosed with partial intestinal obstruction with unspecified cause and had a foreign body in her colon.On (b)(6), 2020, the patient had mesh invading the sigmoid colon and she underwent a colonoscopy flexible with biopsy procedure.It was found out that there were granuloma and plastic woven foreign body encountered -60cm into colonoscopy.In addition, the area was tattooed and tortuous colon.On (b)(6), 2020, the patient had unspecified abdominal pain and sigmoid obstruction with mesh erosion into the sigmoid colon.Furthermore, the patient had undergone a laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy with foreign body excision, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedure.Patient tolerated the procedure well and after a short stay in pacu, she was transferred to the surgical floor in stable condition.Pain medications were transitioned from iv to oral as tolerated.As the patient regained bowel function, her diet was advanced to regular which the patient tolerated well.Subsequently, the patient was discharged.Additionally, the surgical pathology findings from the specimen showed that a 6.0 x 0.6 x 0.3 cm intraluminal foreign body was consistent with mesh within a 0.6 cm defect in the area of tattoo ink.Therefore, the problem was probable consistent with perforation.On (b)(6), 2020, post-operation day 1, the patient felt well, and her pain was well-controlled on ivp dilaudid with standing tylenol.Also, she had no bowel function, and there was tenderness felt on her abdomen.On (b)(6) 2020, post-operation day 2, the patient was on oral pain medications, still with standing tylenol.She felt well, and pain was well-controlled.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a tension-free vaginal tape (tvt) advantage sling placement procedure performed on (b)(6) 2018 to treat genuine stress incontinence.Post-procedure, the patient was not able to void and was given with a foley catheter.On (b)(6) 2018, during her post-operative visit, the foley catheter was removed, and had no other problems.On (b)(6) 2018, during her second post-operative visit for her genuine stress incontinence, the patient still experienced shooting pain to her legs like when she was pregnant.She had no difficulty in voiding.Furthermore, she had not resumed her exercises, but she was able to go back to work and with other activities.Also, her bowel movement was okay but sometimes it was painful.On (b)(6) 2019, the patient was diagnosed with dermoid cyst.She was presented for her annual exam with a good bladder control but ever since, she has had daily discomfort.The patient had a snagging feel on her left side which comes and goes and noted it the most when her bladder was full.However, she was still aware when she was empty.The patient felt like there was a baseline for her discomfort with exacerbations.She felt no pain with intercourse but only felt a little pain after.It was also painful for the patient during working out, however, it would settle.Reportedly, the patient observed that her discomfort was most felt at the left lower quadrant (llq), well above the location of the sling.On (b)(6) 2019, the patient had a surgery consultation for her left ovary dermoid cyst.The patient had an ultrasound which showed a left ovarian cyst and on magnetic resonance imaging (mri), it showed 2 cysts consistent with dermoid.On (b)(6) 2019, the patient had a left ovarian dermoid cyst, abdominal, and pelvic adhesions.She had undergone through right and left fallopian tube, left ovary, left salpingo-oophorectomy, and right salpingectomy.Post-procedure, the findings showed a top normal size uterus sounded to 9cm with a small subserosal fibroid noted, a normal right tube and ovary.Additionally, an enlarged multiloculated left ovary was found at the completion of the case and noted to be a dermoid and adhesions of the descending colon to the ovary and infundibulopelvic ligament as well as mild adhesions of the ovary to the bowel.On october 24, 2019, the patient had a postoperative visit for her dermoid cyst left ovary.It was post-procedure day 20 with no surgical complications.Also, the pathology results showed a mature cystic, and mature teratoma.The patient experienced pain after eating and had constipation in which her stools were little hard.The patient had an appointment on december 19, 2019 for her perimenopausal symptoms that were felt since the surgery.The patient mentioned that her last cycle was on october 29, 2019, and she started to have hot flashes as well.She had a laparoscopic left oophorectomy in october.The patient did have some issues with feeling hotter prior to the surgery but felt that it had worsened since the surgery, especially this month and with her missing cycle.The patient had a colonoscopy procedure on (b)(6) 2020, which revealed a questionable metal mesh at 35cm and occluded the lumen.On (b)(6) 2020, the patient's computed tomography (ct) scan abdominal/pelvic demonstrated a tubular foreign body measuring approximately 4 to 5cm in length in the sigmoid colon.Currently, the patient has small bowel movement daily, and she felt somewhat constipated.She had not taken laxatives, and she rarely had seen a bright red blood per rectum.Moreover, there was no mucus or pus per rectum, and she had no pain felt with bowel movements.The patient has not had a significant weight loss and her appetite was good.However, she felt llq pain that radiates.It had improved somewhat since her ovarian dermoid was removed, but it was not completely resolved.The patient had an mri of the pelvis only done in july 2019, but that was prior the ovarian cystectomy, and did not had taken the image of the abdomen.The mesh/stent could not be seen there.On april 01, 2020, the patient was diagnosed with partial intestinal obstruction with unspecified cause and had a foreign body in her colon.On june 11, 2020, the patient had mesh invading the sigmoid colon and she underwent a colonoscopy flexible with biopsy procedure.It was found out that there were granuloma and plastic woven foreign body encountered -60cm into colonoscopy.In addition, the area was tattooed and tortuous colon.On june 12, 2020, the patient had unspecified abdominal pain and sigmoid obstruction with mesh erosion into the sigmoid colon.Furthermore, the patient had undergone a laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy with foreign body excision, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedure.Patient tolerated the procedure well and after a short stay in pacu, she was transferred to the surgical floor in stable condition.Pain medications were transitioned from iv to oral as tolerated.As the patient regained bowel function, her diet was advanced to regular which the patient tolerated well.Subsequently, the patient was discharged.Additionally, the surgical pathology findings from the specimen showed that a 6.0 x 0.6 x 0.3 cm intraluminal foreign body was consistent with mesh within a 0.6 cm defect in the area of tattoo ink.Therefore, the problem was probable consistent with perforation.On june 13, 2020, post-operation day 1, the patient felt well, and her pain was well-controlled on ivp dilaudid with standing tylenol.Also, she had no bowel function, and there was tenderness felt on her abdomen.On june 14, 2020, post-operation day 2, the patient was on oral pain medications, still with standing tylenol.She felt well, and pain was well-controlled.

Manufacturer Narrative

Additional information: block d4: lot number.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the sling placement.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6) block h6: patient codes e2006, e2101, e1309, e2328, e2317, e2330, e1002, e2114 and e2401 capture the reportable events of sigmoid colon mesh erosion, abdominal, and pelvic adhesions, urinary retention, partial intestinal obstruction, granuloma, pain, left lower quadrant pain, perforation and left ovarian dermoid cyst.Impact codes f1903, and f1901 captures the reportable events of foreign body excision, right and left fallopian tube, left ovary, left salpingo-oophorectomy, right salpingectomy, laparoscopic sigmoidectomy, laparoscopic sigmoid colectomy, sigmoid colectomy, proctoscopy and laparoscopic mobilization of splenic flexure procedures.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh 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.

• Brand Name: ADVANTAGE 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: 12376581
• MDR Text Key: 268428550
• Report Number: 3005099803-2021-04382
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0021825580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White