MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN ANTERIOR PELVIC FLOOR GRAFT; PELVIC FLOOR ANTERIOR

Catalog Number J-PF-ANT-SSL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Impaired Healing (2378)

Event Date 06/11/2014

Event Type  Injury  

Manufacturer Narrative

Investigation - evaluation investigation into this feedback included 1) a review of the feedback, 2) a review of the device lot history record, 3) a review of the cbi complaint database, 4) a review of the biodesign surgisis anterior pelvic floor graft ifu fp0091-01a.Summary of investigation findings a review of the device lot history record indicated the device was manufactured to specifications.A total of (b)(4) devices was produced from the lot.The review of the device lot history records indicated that the (b)(4) devices released for distribution met the final inspection specification requirements.A review of the cbi complaint database did not reveal any additional complaints involving the reported lot number.Per the ifu, the following complications are possible with the use of surgical graft materials: exposure in the vagina, pelvic pain, de novo dyspareunia, vaginal scarring, atypical vaginal discharge, foreign body reaction, wound dehiscence, need for revision/resurgery, de novo voiding dysfunction including incontinence, neuromuscular complications, infection, erosion into another organ, chronic inflammation, vaginal shortening, de novo vaginal bleeding, sterile effusion, adhesion formation, failed graft incorporation, bladder/bowel/nerve injury, and bleeding/hemorrhage.If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of graft.The root cause of the patient's reported injury is inconclusive.The ifu lists the potential known complications and guides the user on use of the device.Without factual details from the patient's medical record and/or operative reports, a root cause cannot be defined.Many factors can contribute to the patient's reported injury, including, but not limited to, underlying patient condition(s) being treated, other patient medical/surgical history, user technique, and patient's compliance with post-op care/instructions.

Event Description

Clinical event information: cook surgisis pelvic mesh prosthetic initial insertion surgery on (b)(6) 2013 at [hospital redacted] by [surgeon redacted].Product ref (b)(4).Ref (b)(4).Lot lbg75800.Revision surgery on (b)(6) 2014 to excise part of the mesh which had eroded through my vaginal wall, performed again by [surgeon redacted] at the [hospital redacted].Ongoing problems with mesh erosion, mesh exposure, debilitating pain, further incontinence, nerve pain, painful intercourse as well as injury to partner due to mesh cutting through vaginal wall and into my partners penis.Patient outcome/consequences: due to the cook medical surgisis pelvic mesh implant i now have to live with debilitating pain, bladder and bowel incontinence and can no longer enjoy sexual intercourse with my husband which is placing a lot of stress on my marriage.

• Brand Name: BIODESIGN ANTERIOR PELVIC FLOOR GRAFT
• Type of Device: PELVIC FLOOR ANTERIOR
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer (Section G): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: chris lotzow ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 16308902
• MDR Text Key: 308915376
• Report Number: 1835959-2023-00001
• Device Sequence Number: 1
• Product Code: PAG
• UDI-Device Identifier: 10827002555997
• UDI-Public: (01)10827002555997(17)150331(10)LB675800
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: J-PF-ANT-SSL
• Device Lot Number: LB675800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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 Sex: Female