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

Device Problem Material Erosion (1214)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Swelling (2091); Bowel Perforation (2668); 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.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: can urol assoc j.2015; 9(3-4): e208-9.Doi: http://dx.Doi.Org/10.5489/cuaj.2680.(b)(4).

Event Description

It was reported via journal article "title : delayed sigmoid colon perforation and enterocutaneous fistula due to tension free transvaginal tape operation for stress urinary incontinence" author: in kyu lee, md, phd;* dong wan sohn md, phd citation: can urol assoc j.2015; 9(3-4): e208-9.Doi: http://dx.Doi.Org/10.5489/cuaj.2680.The authors recently experienced the case of delayed detected sigmoid colon perforation and enterocutaneous fistula due to tvt tape operation after 7 years.A (b)(6) female patient complained of left lower abdominal tenderness and swelling for 2 weeks.Her right thigh was also tender and swollen.The patient underwent tvt procedure using gynecare tvt (ethicon) 7 years ago.Five months prior to presentation, it was reported that the patient had prior vaginal erosion of the tvt tape which required removal of the suburethral polypropylene mesh.However at that time, complete removal of the mesh was impossible because pulling the right part resulted in snapping of the mesh adhered to the tissue.The patient¿s computed tomography examination revealed perforation of sigmoid colon, enterocutaneous fistula, and subcutaneous abscess which required laparoscopic sigmoid colon wedge resection and excision of the mesh completely in sigmoid colon and peritoneal wall.It was reported that when an anti-sui surgery is performed, the surgeon should be wary to prevent bowel injury.If bowel injury is suspected, immediate exploratory laparotomy is necessary.Laparoscopic surgery is safe and efficacious method to remove the tape and repair the bowel.

• 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: 7940687
• MDR Text Key: 123052397
• Report Number: 2210968-2018-76355
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/12/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/05/2018
• 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: 56 YR