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 Problem Hematoma (1884)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Following initial implant procedure on (b)(6) 2016, patient remained in hospital for monitoring of acute systolic congestive heart failure and intravenous diuresis for fluid retention and having greater than 12 liters of fluid removed.Patient was discharged on (b)(6) 2016.Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9-26-2016 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 risk of hematoma as a potential complication.The site investigator for this study indicated that the probable cause of this event was related to the fact that patient was on blood thinners for atrial fibrillation.The device remains implanted with no further incidents/events reported.

Event Description

It was reported that a cormatrix cangaroo ecm envelope (model #cmcv-009-lrg lot# m16k1253) was hydrated in 1 gram vancomycin in 1000 milliliters normal saline, and used in a bi-ventricular automatic implantable cardioverter defibrillator procedure on a (b)(6) male patient with a history for infection from diabetes and congestive heart failure.The date of implant was (b)(46 2016 and no issues were identified at time of treatment.At 1 week follow-up on (b)(6) 2016, the site had active oozing of old blood from small, soft hematoma with sanguineous discharge.Physician performed a pocket revision and incision to allow drainage of hematoma on (b)(6) 2016.Cultures taken were negative for bacterial growth and no antibiotics were recommended.The site investigator indicates that the relationship of the event to the procedure and the device were probably related.The site investigator further indicates that, in his opinion, the probable cause of the event was that the patient was on blood thinner for atrial fibrillation.The event resolved on (b)(6) 2016 without sequelae.The device remains implanted with no further incidents 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: 6333229
• MDR Text Key: 67534090
• Report Number: 3005619880-2017-00005
• 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
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/16/2018
• Device Model Number: CMCV-009-LRG
• Device Lot Number: M16K1253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR