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); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)

Event Date 08/30/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with graft, cuff suspension with graft, and posterior repair procedure performed on (b)(6) 2017, for the treatment of recurrent prolapse with an estimated blood loss of 200 ml.On (b)(6) 2019, the patient underwent vaginal mesh excision and a cystoscopy procedure for the treatment of atrophic vaginitis and a sensation of pressure in the bladder area.Moreover, the patient presented with an extensive history of reconstructive pelvic floor surgery, who had complaints of pelvic pain and vaginal spotting in the setting of apical mesh exposure in the vagina and desired surgical management.She does have a history of chronic pain, including evidence of levator spasm on exam.She also reported that she experienced urinary urgency and bladder discomfort at times with a very full bladder.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2017, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states, phone number: (b)(6).The revision surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states.(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.

• 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: 15094304
• MDR Text Key: 296492176
• Report Number: 3005099803-2022-04062
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2022

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: 02/17/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000056826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female