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 Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 was implanted on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; pain inter; inab inter; off vag dis; diff bowel; rec incont nonsurgical treatments: on (b)(6) 2021 the patient commenced other medication (please specify): ibilex 250mg for the treatment of: long term interstitial cystitis.Treatment duration: 6 months.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: soften the vaginal wall.Treatment duration: continuous.On (b)(6) 2021 the patient commenced other (please specify) for the treatment of: soften vaginal walls.Treatment duration: continueous.

Manufacturer Narrative

Additional information to blocks a1: patient's initials, b5, d4: lot number, e1: physician's name and healthcare facility, g4: premarket 510k, and h4: manufacture date.Block a1: (b)(6).Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Block h6: patient code e2330 captures the reportable event of pain (back pain, vaginal pain, pelvic pain).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted during an anterior vaginal repair with apical fixation using uphold mesh, posterior vaginal repair, perineoraphy, and cystoscopy procedure performed on (b)(6), 2012.The postoperative findings of the patient were grade 2 cystocele, vault prolapse grade 1, and rectocele grade 1.There was significant scar tissue between the anterior vaginal wall and the bladder.Additionally, the cystoscopy results showed no mesh in the bladder.The bladder was normal in appearance, and there was no evidence of detrusor activity.Post-procedure, the patient experienced complications and nonsurgical treatment(s).Patient symptoms include: back pain, vaginal pain, pelvic pain, painful intercourse, inability to have sexual intercourse, offensive vaginal discharge, difficulty in bowel movement, and recurrent incontinence.Nonsurgical treatments: on (b)(6) 2021, the patient commenced medications such as ibilex 250mg for the treatment of long-term interstitial cystitis for the duration of 6 months.The patient was also treated with topical treatment, ovestin cream (including oestrogen cream) to soften the vaginal wall continuously.

• 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: 12930683
• MDR Text Key: 286869617
• Report Number: 3005099803-2021-06892
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

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: 05/31/2015
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00000705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 74 KG