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

Model Number M0068317080

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Scar Tissue (2060); Urinary Retention (2119); Prolapse (2475); Hematuria (2558); Ascites (2596); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of the patient's first reported visit to the physician.This event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).(b)(6) 2021 surgery: (b)(6).(b)(4).The complaint device 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

Note: this manufacturer report pertains to the first of two devices used during the procedure.It was reported to boston scientific corporation that uphold vaginal support system and obtryx system - curved devices were implanted into the patient during an anterior colporrhaphy, sacrospinous ligament fixation, vaginal mesh placement, cystoscopy with urethral calibration, placement of suprapubic tube and transobturator tape - obtryx procedures performed on (b)(6) 2010 for the treatment of bladder prolapse and stress urinary incontinence.On (b)(6) 2020, the patient visited the physician with complaints of lower urinary tract symptoms.Reportedly, the patient did not have a good size and strength to her urinary stream.Her urinary stream did not start and stop during voiding.She did dribble at the end of urination; however, she felt that she was emptying her bladder well.The patient reportedly got up at night to urinate 5+ times and leaked urine when had a strong urge to void.Additionally, she had seen blood in her urine.The symptoms had then gotten worse over the last year and she was not satisfied with the way she was voiding.Assessment of the physician includes overactive bladder, urge incontinence, incomplete bladder emptying and hematuria.She was then scheduled for a surgery on (b)(6) 2020.On (b)(6) 2021, due to mesh erosion into vaginal wall, vaginal atrophy (also treated with vaginal estrogen cream), cystocele, rectocele, urge incontinence, cirrhosis of the liver with ascites, mitral valve insufficiency and pericardial effusion, the patient underwent the following procedures: vaginal removal of apical/anterior mesh kit; anterior colporrhaphy; adjacent tissue transfer with vaginal advancement flap; and cystoscopy.During the procedure, a 2.5 x 1 cm of exposed mesh banding at the apex was noted and it was discovered that it was the uphold mesh that was exposed.On cystoscopy, the patient has cystitis cystica.No injury to the bladder noted.The patient was then taken to pacu in good condition after the procedure.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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: 12373028
• MDR Text Key: 268322279
• Report Number: 3005099803-2021-04196
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 1ML0072002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR