MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX CANGAROO ECM ENVELOPE; MESH, SURGICAL

Model Number CMCV-009-LRG

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the device history record for the reported lot shows that all units were quality released on 09/13/2016 having met all internal manufacturing specifications and qc acceptance requirements for workmanship and biological indicator testing for product sterility.The instructions for use for the cormatrix cangaroo ecm envelope ((b)(4)) currently lists the risks of infection and hematoma as potential complications.The site investigator indicates that in their opinion, the probable cause of the event is related to the patient's history of blood thinner usage.The device remains implanted and no further incidents/events have been reported.

Event Description

It was reported that a cangaroo ecm envelope (model # cmcv-009-lrg lot# m16k1239) was hydrated in a 1 gram vancomycin/1000 milliliter normal saline solution and implanted into a (b)(6) male patient with a history of smoking and congestive heart failure.The upgrade/change-out procedure used a bi-ventricular defibrillator and was performed on (b)(6) 2016 with no issues during procedure.On (b)(6) 2016 patient was admitted to hospital for small soft hematoma with slight odor and old dark blood.The reported event resolved without intervention, possible cellulitis to pocket that was resolved on (b)(6) 2016 with intravenous vancomycin without sequellae.At the 4 - 6 week follow-up visit no issues were reported.Site investigator reports that the intensity of event was moderate, and the relationship of the event to the procedure and device were probably related.In the opinion of the investigator, the event was probably caused from the history of blood thinner usage.The device remains implanted with no further incident/events reported.

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• Manufacturer (Section G): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• Manufacturer Contact: andrew green ; 1100 old ellis road; roswell, GA 30076 ; 4705144019
• MDR Report Key: 6333235
• MDR Text Key: 67534343
• Report Number: 3005619880-2017-00006
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005065
• UDI-Public: 00859389005065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/01/2018
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M16K1239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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
• Treatment: BI-VENTRICULAR DEFIBRILLATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR