MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR PERICARDIAL CLOSURE; PATCH, PLEDGET AND INTRACARDIAC

Model Number	CMCV-060-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event used cormatrix ecm for pericardial closure product for an off-label use in an application more closely associated with the cormatrix ecm for cardiac tissue repair.Both products are identical, only the associated labeling and cleared indication for use are differentiated between the two products.The associated instructions for use with the pericardial closure product (art-20551a) states that the product is intended for the reconstruction of the pericardium.The cardiac tissue repair instructions for use (art-20553a) states that the product is intended for use as an intracardiac patch or pledget for tissue repair [i.E., atrial septal defect (asd), ventricular septal defect (vsd), etc.] and suture-line buttressing.Neither product is intended for a conduit graft completely replacing previous patient tissue/vessel, and would represent an off-label use for either device.Physician states that he "was pleasantly surprised about what he saw" upon re-opening patient and observing the integration of the cormatrix ecm and noting it was still strong, but overgrown in diameter most likely associated with the original diameter determined when forming the ecm material to replace the aortic section during original aortic repair.A review of manufacturing records associated with manufacturing lot m15f1167 shows no manufacturing/sterilization related nonconformances and that all quality requirements for the packaged product were met prior to release to distribution.No additional information is available regarding the explanted tissue from the hospital pathology lab, should any additional details be provided by the hospital a follow-up report will be submitted.
Event or Problem Description
It was reported that a cormatrix ecm for pericardial closure (model cmcv-060-402, lot #m15f1167) was used on a (b)(6) male patient weighing (b)(6).The 7cm x 15cm piece of ecm was used in an aortic arch reconstruction procedure in the left chest on (b)(6) 2015.The patch had been hydrated in a saline solution for approximately two minutes.Approximately one year later, on (b)(6) 2016, a resection of the dilated cormatrix conduit was completed and replaced with a goretex conduit.There was no initial onset of symptoms or serious adverse event/malfunction that dictated the resection and replacement of the cormatrix ecm.The physician determined during subsequent follow-up that the aortic repair appeared dilated and posited that the dilation may be the early signs of an aneurysm and decided to re-operate and replace.Upon re-opening patient, surgeon determined that the cormatrix patch had completely integrated and was still strong, but was just overgrown to double the diameter of the patient's aorta.No stenosis was observed.The explanted ecm was sent to hospital pathology for evaluation.

• Brand Name: CORMATRIX ECM FOR PERICARDIAL CLOSURE
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• MDR Report Key: 6509130
• Report Number: 3005619880-2017-00012
• Device Sequence Number: 1642046
• Product Code: DXZ
• UDI-Device Identifier: 00859389005010
• UDI-Public: 00859389005010
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K051405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2017

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
• Operator of Device: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: CMCV-060-402
• Device Lot Number: M15F1167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2016
• Initial Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Weight: 10