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

Model Number CMCV-009-MED

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

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

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

The site investigator noted that the event is possibly related to the procedure, and probably related to the device, however the exact relationship to the device cannot be conclusively determined as the device was neither returned for evaluation, nor was the pocket or wound swabbed for cultures.Additional questions have been presented to the site and implanting physician and a follow-up report will be submitted if any additional information is received impacting the results or conclusions of this report.The instructions for use for the cangaroo ecm envelope currently lists infection and hematoma as potential complications associated with the procedure and device.A review of manufacturing records for the reported lot has shown that all manufacturing and inspection criteria were met for this lot including product sterility testing supporting the release of this manufacturing lot.

Event Description

It was reported that a cangaroo ecm envelope (cmcv-009-med lot #m16d1119) was used during a pacemaker implant procedure performed on (b)(6) 2016 on an (b)(6) male with no reported risk factors for infection.The cangaroo ecm envelope was hydrated in vancomycin, and the patient received iv antibiotics pre-treatment.At the wound check conducted on (b)(6) 2016 a 3 cm hematoma was noted at the implant site with an onset date of (b)(6) 2016 determined by physician.The site looked good with resolution of the hematoma and no signs of infection.On (b)(6) 2016, patient presented to the emergency room with complaints of sepsis, fever of 103 degrees, abdominal pain, and blood in urine.At time of er visit the left upper chest was mildly tender at pacemaker site, patient discharged with diagnosis of acute cystitis (uti) and given oral antibiotic and tylenol for fever.On (b)(6) 2016 pacemaker was explanted and patient admitted for infection by iv antibiotics.Patient was discharged from hospital on (b)(6) 2016 and event had resolved at the next office visit on (b)(6) 2016.

Manufacturer Narrative

Per information received from the site, they reported that the doctor does not believe the event was related to the ecm device.The probable cause of the event was listed as, "allergic reaction to foreign body (cied)".The updated form received from the site states the event is not related to the device.

• 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: 6416626
• MDR Text Key: 70302213
• Report Number: 3005619880-2017-00010
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• 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,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/23/2016
• Device Model Number: CMCV-009-MED
• Device Lot Number: M16D1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: BIOTRONIK PACEMAKER
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR