MAUDE Adverse Event Report: BOVINE PATCH; PATCH, PLEDGET AND INTRACARDIC, PETP, PTPC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Seizures (2063); Sepsis (2067)

Event Date 11/02/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, my husband had femoral artery surgery and a bovine patch was used.On (b)(6) 2016, 911 was called he was bleeding back to surgery.On (b)(6) 2016, 911 again given 2 units of blood in er back to surgery stayed in hosp; (b)(6) 2016 started bleeding in hosp back to surgery.Came home (b)(6) 2016 911 called, given blood, eyes rolled back in, head back to surgery stayed in hosp; (b)(6) 2016 back to surgery, started bleeding again, put on ventilator for 7 days.On (b)(6) 2016 aspirated fluid upper right lung, temp 105.On (b)(6) 2017 ventilator removed, (b)(6) 2017 ng tube removed, (b)(6) 2017 home.On (b)(6) 2017 911 called, seizure due to being septic, stayed in hosp; (b)(6) 2017 started bleeding, (b)(6) 2017 back on ventilator.On (b)(6) 2017 in am, back to surgery to do wound vac change, (b)(6) 2017 afternoon started bleeding again, back to surgery, dr finally went back down to the femoral artery found it was infected, replaced it with vein from husband's right arm.On (b)(6) 2017 moved from hosp to rehab.On (b)(6) 2017 discharged home.From (b)(6) 2016 to (b)(6) 2017 dr took him into surgery twice a week to change his wound vac putting him under anesthesia every time.He was treated for infection from approx (b)(6) 2016 to (b)(6) 2017.He now can hardly walk and the seizure has caused a change to his speech, memory, and he has become very combative to the point that his dr's partner put him on drug to help keep him calm.

• Brand Name: BOVINE PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIC, PETP, PTPC
• MDR Report Key: 7902005
• MDR Text Key: 121858130
• Report Number: MW5080071
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 61 YR
• Patient Weight: 114