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

Model Number CMCV-006-609

Device Problem Material Separation (1562)

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Pain (1994); Paralysis (1997)

Event Date 04/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, cormatrix cardiovascular rec'd details of an event involving the use of cormatrix ecm for carotid repair.Details of the event are provided below.It was reported that a male pt, in his 60s, experienced a patch dehiscence after a carotid endarterectomy angioplasty with the cormatrix ecm for carotid repair.The endarterectomy was performed at a different hospital and by a different surgeon than the initial rptr.Approx 2 weeks after the procedure, the pt was admitted to the emergency room with pain and left arm paralysis.The ct scan showed what appeared to be a bleeding pseudoaneurysm at the site of the endarterectomy.Emergency surgery was performed on (b)(6) 2014.When the site was opened, there was no pseudoaneurysm present but profuse bleeding.The patch had dehisced along the lateral suture line.The sutures were found intact and untorn.The attending surgeon indicated that from what he could tell, the ecm patch had been sutured in place correctly.The patch was removed and replaced with a different product.The pt's neurological issues (pain and left arm paralysis) resolved approx 6 hrs following the repair surgery while the pt was in the recovery room.It was reported that the pt is currently doing fine.

• Brand Name: CORMATRIX ECM FOR CAROTID REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; sunnyvale CA
• Manufacturer Contact: andrew green ; 1100 old ellis road; roswell, GA 30076 ; 4705144019
• MDR Report Key: 3827617
• MDR Text Key: 4453888
• Report Number: 3005619880-2014-00020
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMCV-006-609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2014
• 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