MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX ECM FOR VASCULAR REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	CMCV-013-609
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint log shows that this is the only complaint associated with this lot number.Fda's prp report number: mw5075072, mw5075090, and mw5075091 were received from the fda in a letter dated february 13, 2018 in reference to this incident/event.It was determined that all three events have been identified and processed through the complaint system.Manufacturing review of the device history record for the reported lot shows that all units were quality released on 10/8/2015 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.Oem review of the sub-lots associated with the reported lot and provided specific disposition details of non-conformances.It was stated that, "based upon the review results, the non-conformances had no impact on the reported issue." the ifu instructions for the vascular product that was provided with the product (part number 20438-032514) indicates under warnings and precautions, "excessive hydration may result in delamination.If delamination is observed, do not use the cormatrix ecm.Device is not recommended to be used with glue containing glutaraldehyde.Device must be sutured to viable native tissue and must not be sutured to synthetic or chemically cross-linked materials.Device is not recommended to be used with platelet gel." the ifu also states in the instructions for use, "hydrate the cormatrix ecm by placing it in a bowl of sterile saline or other sterile isotonic solution for approximately 1-2 minutes prior to use.Use at least 50 ml of the sterile solution for hydration.It is recommended that the ecm not be excessively handled or manipulated prior to use." reports of aneurysm were found to be within expected occurrence ratings identified in the risk management files.Based on the low frequency of occurrence and inconclusive root cause, no further corrective action is required at this time.
Event or Problem Description
It was reported that a cormatrix ecm (cmcv-013-609, lot # m15l1279) was used for a carotid procedure (exact details unknown) on a (b)(6) male with an implant date of (b)(6) 2015 and date of event/explant on (b)(6) 2018*.It is stated that the ecm and soak time was prepared "per manufacturer's instructions".The event was originally reported as, "aneurysm of carotid artery at site of implant.Will require surgical explant 2/2" (as of forms received on 2/5/2018).The ecm was sutured to the patient tissue.The surgeon believes that the event was probably related to the procedure and probably related to the device.The probable cause is listed as, "product degradation".*it can be noted that it was stated, "new graft (not aziyo/cormatrix) implanted which is now occluded within 2 weeks of second operation that occurred on (b)(6) 2018.Patient is doing bad.".

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 7375141
• Report Number: 3005619880-2018-00002
• Device Sequence Number: 993209
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 01/31/2017
• Device Model Number: CMCV-013-609
• Device Lot Number: M15L1279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• 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: 62 YR