MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Urinary Frequency (2275); Hematuria (2558); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (tension free vaginal tape) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? citation: urology 114: e7¿e8, 2018.Doi: https://doi.Org/10.1016/j.Urology.2017.12.026 please see referenced article attached.(b)(4).

Event Description

Title : a delayed appearance of the secondary bladder stone 10 years after tension-free vaginal tape procedure a (b)(6) woman was presented to the urology department with new-onset urinary frequency and gross hematuria over several days (new-onset urinary frequency and gross hematuria).Previously (10 years prior to presentation), it was reported that the patient underwent tension-free vaginal tape (tvt) surgery using gynecare tvt device (ethicon) for stress urinary incontinence.Surveillance imaging revealed a stone adherent to the bladder wall.Following laser fragmentation of the stone, the artificial tape was identified, which was compatible with the previous tvt procedure.Holmium laser was used to cut the intravesicle tape and allow the residual tape to merge into the bladder wall.Cystoscopy 1 month after surgery showed healed bladder mucosa without exposed tape and stone in bladder.In this case, symptomatic secondary bladder stone occurring 10 years after a previous tvt procedure is rare and probably due to the slow migration of the tape, which caused a delayed development of bladder stone.The authors noted the possibility of an iatrogenic bladder stone even a decade after the anti-incontinence procedure.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7932617
• MDR Text Key: 122663091
• Report Number: 2210968-2018-76309
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• 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): Required Intervention
• Patient Age: 76 YR