MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

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

Patient Problems Erosion (1750); Fistula (1862); Perforation (2001); Prolapse (2475); Hematuria (2558)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The implant and explant surgeon is: (b)(6).(b)(4).The removed mesh 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 lite mesh with capio slim device was implanted into the patient during an anterior colporrhaphy with insertion of uphold mesh procedure performed on (b)(6) 2017 to treat recurrent cystocele.During the procedure, dissection on the patient's left side was somewhat more tedious because of the prior surgery and the scar tissue in the vaginal wall.Cystoscopy was performed and noticed that part of the suture was piercing the bladder so that the arm was removed and redirected and replaced in the sacrospinous ligament.Again, cystoscopy was performed and confirmed that no sutures were noted in the bladder and the integrity of the bladder was confirmed.On (b)(6) 2019, the patient was diagnosed with hematuria and vaginal mesh erosion into the bladder mucosa; and underwent cystourethroscopy.On (b)(6) 2020, the patient had surgical intervention for mesh removal.All the mesh was completely removed and the patient was taken to recovery room under stable and satisfactory condition.On (b)(6) 2020, the patient was diagnosed with a 2mm vesicovaginal fistula, erosion of vaginal mesh into bladder and recurrent vaginal prolapse.The patient underwent cystoscopy with ureteral stent placement, bilateral and vesicovaginal fistula repair.

• Brand Name: UPHOLD LITE
• 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
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12369741
• MDR Text Key: 268204812
• Report Number: 3005099803-2021-04345
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000032828
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR