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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

A root cause for this reported event cannot be established at this time.Physician reports that patient exercised poor judgement for follow-up care, no indication by physician as to whether cause of dehiscence related to device or procedure or patient comorbidities/care during recovery period.Patient pre-existing conditions include congestive heart failure, cardiomyopathy, and previous implantable cardioverter defibrillator surgery.

Event Description

It was reported that a (b)(6) male with a history of congestive heart failure, cardiomyopathy, and previous implantable cardioverter defibrillator with depleted battery required a generator change-out with a cangaroo ecm envelope device placed on (b)(6) 2016.On (b)(6) 2016 patient presented in the physician's office with a pacemaker incision which had dehisced in 2 or 3 places.Device was explanted.No further information provided, should additional information be provided by user an update report will be filed.

• 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: 6010892
• MDR Text Key: 56801635
• Report Number: 3005619880-2016-00028
• Device Sequence Number: 1
• Product Code: FTM
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR