MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041

Device Problems Material Erosion (1214); Material Perforation (2205)

Patient Problems Bleeding (1738); Erosion (1750); Internal Organ Perforation (1987); Urinary Retention (2119); Surgical procedure (2357); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on an unknown date.The patient experienced a mesh exposure resulting in a small bladder perforation which was managed with an indwelling catheter for 36 hours.The patient was still continent.The patient presented with postmenopausal vaginal bleeding on (b)(6) 2014.Upon examination, exposed mesh was noted above the right vaginal sulcus.The patient was prescribed topical estrogen.There is a plan for cystourethroscopy, exploration of the exposed mesh, vaginoplasty or mesh excision and resuturing of vaginal depending on findings under anaesthesia.No further information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent sling procedure on (b)(6) 2003 and mesh was implanted.The patient experienced a small bladder perforation with trocars on the right side and the bladder perforation was found before pulling mesh through.During follow-up in (b)(6) 2004, patient was happy with slightly slowed urinary stream and during follow-up in (b)(6) 2004 patient was happy with no symptoms.On (b)(6) 2014, the patient underwent cystourethroscopy, exploration of exposed mesh, excision of granulation tissue and vaginoplasty with no excision of mesh due to containment.The patient remains continent and will be followed up in three months.

• Brand Name: GYNECARE TVT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3931283
• MDR Text Key: 4573642
• Report Number: 2210968-2014-09051
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

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 Catalogue Number: 830041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 07/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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