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

Model Number CMCV-009-MED

Device Problem Insufficient Information (3190)

Patient Problem Pocket Erosion (2013)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

No sample is available for evaluation.No additional information is currently available.The cause of the event is unknown.The manufacturing records for lot m15h1227 have been reviewed.There were no deviations or nonconformances that could have caused or contributed to the reported event.This is the only event associated with lot m15h1227 to date.

Event Description

On (b)(6) 2015 cormatrix cardiovascular became aware of an event possibly involving the use of cormatrix ecm envelope.Details are provided below: it was reported that a (b)(6) year old male patient had a placement of an icd device along with the cangaroo ecm envelope device on (b)(6) 2015.The patient was in for a wound check and no issues were identified.During the 4 - 6 week visit on (b)(6) 2015, it was noted that the lateral posterior corner of the device had a quarter size area of discoloration and was tender to touch.A pocket revision was completed on (b)(6) 2015 due to icd pocket erosion.

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Type of Device: SURGICAL MESH
• 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: 5383980
• MDR Text Key: 36584485
• Report Number: 3005619880-2016-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2016

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
• Device Expiration Date: 10/20/2016
• Device Model Number: CMCV-009-MED
• Device Lot Number: M15H1227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2014
• 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: 57 YR
• Patient Weight: 73