MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR CARDIAC TISSUE REPAIR; PATCH, PLEDGET AND INTRACARDIAC

Model Number CMCV-064-401

Device Problem Delamination (2904)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Sample has been retained by european distributor, and shipped to cormatrix for evaluation.As of this filing, sample has not been received for further evaluation.A follow-up report will be filed as soon as sample has been received and evaluated for potential root cause.No patient involvement associated with this product malfunction, and another cormatrix device utilized for procedure without incident.The cormatrix ecm for cardiac tissue repair is indicated 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.The cormatrix ecm for cardiac tissue repair is not indicated for pulmonary valve replacement as is reported in this event.Additionally, the instructions for use (20462-062014) provides warnings and precautions to user to "discard the device if mishandling has caused possible damage or contamination" as well the user is instructed to not implant the device if delamination is observed after trimming.Review of cormatrix manufacturing records shows that identified lot was released having met all requirements for release with no nonconformances or deviations noted.Further investigation is in process with component suppliers and will be included in follow-up report when information is available.

Event Description

It was reported that on (b)(6) 2016, a 7cm x 10cm cormatrix ecm for cardiac tissue repair (cmcv-064-401 lot# m16h1192) was being prepared for a pulmonic valve application (off-label use) on the "dry table'.The 7cm x 10cm piece of tissue was observed to be unusually thick, and then the tissue separated into two layers.The ecm tissue had not been hydrated at the time of observing the delamination.The surgeon abandoned creating the valve with this piece of tissue, and proceeded to take another 7cm x 10cm package of cormatrix ecm for cardiac tissue repair from the shelf and complete the procedure.

Manufacturer Narrative

Actual device received for evaluation by cormatrix.Visual inspection of the returned sample confirmed that the original ecm sheet (7cm x 10cm) had been trimmed to approximately 5.6cm x 7cm in size.The trimmed piece of tissue had one corner raised indicating separation of the original four layers into two layers (each resulting layer containing 2 bound ecm layers).The area of separation did not encompass the entire trimmed piece of ecm, only an approximate triangular shape emanating from one corner down one side of the tissue approximately 3.1cm, and the adjacent side approximately 4.6cm.The area of delamination appeared to coincide with the markings placed on the ecm sheet in the planning phase of preparing the creation of the valve.The tissue was also measured for thickness as the physician indicated in the initial report of the material being "unusually thick".As the ecm material is a biologic material, there is expected variation associated with the lamination of 4 layers of submucosal intestinal tissue.As such, there is no dimensional specification associated with material thickness.Thickness measurements recorded for the retuned piece showed a range of 0.15mm from one edge of the tissue to the other in the dry state (e.G.Worst case).While delamination was observed in the investigation, the root cause of the delamination could not be definitively identified.It is suspected that the delamination is a result of excessive handling and manipulation of the ecm attempting to prepare the trimmed piece of ecm for the off-label valve usage.

• Brand Name: CORMATRIX ECM FOR CARDIAC TISSUE REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC
• 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: 6251921
• MDR Text Key: 64900970
• Report Number: 3005619880-2017-00001
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00859389005041
• UDI-Public: 00859389005041
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: CMCV-064-401
• Device Lot Number: M16H1192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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): Other