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 Insufficient Information (4580)

Event Date 07/29/2008

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2008 was chosen as a best estimate based on the date of the mesh was implanted.Blocks 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 implanting physician is: (b)(6).Block h6: the following imdrf patient code captures the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code captures the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.

Event Description

It was reported to boston scientific corporation that the polyform synthetic mesh device was implanted into the patient during an anterior repair with mesh augmentation, sacrospinous suspension, and suburethral sling for incontinence during a transobturator approach procedure on (b)(6) 2008, for the treatment of grade-3 cystocele, uterine descent, vaginal prolapse, and incontinence.Panendoscopy of the bladder revealed no intravesical lesions.There was no bladder injury following the passage of the sling needles and/or repair.Notably, there was calcified structure going along the arcuate line on palpation of the right side.The surgeon is unsure if this is a calcified vessel because there was no pulsation on it.During their suspension repair, he kept a safe distance from this structure.Despite this, the patient tolerated the procedure well and was discharged in good condition with a foley catheter in place.As reported by the patient's attorney, the patient has experienced an unspecified injury as a result of the surgery.

• 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, co galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16883737
• MDR Text Key: 314709878
• Report Number: 3005099803-2023-02262
• 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: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female