MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLYFORM SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

Model Number M0068402400

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

Patient Problem Prolapse (2475)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e2333 captures the reportable event of recurrent prolapse.Imdrf impact code f1905 captures the reportable event of mesh revision.Imdrf impact code f2203 captures the reportable event of cystoscopy procedure.Imdrf impact code f1901 captures the reportable event of lysis of adhesion of ovary.

Event Description

It was reported to boston scientific corporation that a polyform device was implanted during a procedure performed on (b)(6) 2009.The patient has a complicated surgical history.The patient then underwent laparoscopic scp with polyform mesh, pr, cystoscopy in 2009, and subsequently a mid-urethral sling (monarc tot) and cystoscopy in 2011.After a hernia repair surgery 2-3 years ago, the patient noted constant vaginal discharge.She underwent laparoscopic excision of infected mesh and sutures on (b)(6)2021.At her 4-month post-op appointment, she said no further vaginal discharge but a recurrence of prolapse symptoms.She was found to have stage ii vaginal prolapse and desired definitive surgical management.On (b)(6) 2022, the patient then underwent laparoscopic sacro colpopexy, cystoscopy, and lysis of adhesion of ovary for the treatment of vaginal vault prolapse after hysterectomy, on exam under anesthesia, stage ii vaginal prolapse, anterior wall predominant.On laparoscopy, filmy bowel adhesions were noted in the posterior cul-de-sac and the vaginal cuff (left > right).These were taken down with a combination of sharp and blunt dissection without difficulty.Surgically absent uterus, bilateral fallopian tubes, and ovaries.Anterior abdominal wall hernia mesh rlq (right lower quadrant) and suprapubic area to the right of the midline.Standard liver edge and stomach.The area of mesh at the sacrum spanned approximately 3-4 cm into the pelvis, which was noted to be near the right ureter.This tail of the previously placed sacro colpopexy mesh (polyform) was used to affix the newly placed sacro colpopexy mesh to the sacrum.On cystoscopy, no tumors, stones, or masses.No injury to the bladder or urethra.Normal ureteral orifices with brisk ureteral jets bilaterally.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18100283
• MDR Text Key: 327714307
• Report Number: 3005099803-2023-06022
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Device Lot Number: C000798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR