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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Incontinence (1928); Pain (1994); 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 following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases 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: can urol assoc j 2013; 7(9-10):e598-600.Doi: http://dx.Doi.Org/10.5489/cuaj.393.(b)(4).

Event Description

It was reported via journal article: "title: a severe complication of mid-urethral tapes solved by laparoscopic tape removal and ureterocutaneostomy" author(s): tobias schätz, md; stephan hruby, md; daniela colleselli, md; günter janetschek, md; lukas lusuardi, md citation: can urol assoc j 2013; 7(9-10):e598-600.Doi: http://dx.Doi.Org/10.5489/cuaj.393.This study presented an (b)(6) female patient who underwent tension-free vaginal tape (tvt, gynecare) procedure for persistent stress urinary incontinence.In (b)(6) 2010, she presented with perineal pain, continuous incontinence and offensive smelling.Urine culture was positive for e.Coli and cystoscopy revealed small mid-urethral stone adherent to the eroded tape in the 6-o¿clock position.Vaginal examination revealed presence of vaginal fistula.The urethral stone was totally removed with cold cup biopsy forceps and the underlying tape was divided and partially removed.There was an unsuccessful attempt to remove the eroded tape from the lateral sides of the bladder neck and a suprapubic catheter was inserted.Cystography confirmed the urethro-vaginal fistula.Post-treatment, the patient developed pain and swelling of the mons pubis which a 6cm fluid was found on ct scan.She was still incontinent and in pain.She underwent removal of the tape and perform bilateral uretrocutaneostomy using minimally invasive techniques.Laparoscopic surgery to remove the tape was safe and efficacious in this unfortunate scenario.Laparoscopy can also provide an effective solution for incontinence in an elderly, comorbid patient.

• 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: 8043833
• MDR Text Key: 126371194
• Report Number: 2210968-2018-76990
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• 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: 85 YR