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

Model Number	CMCV-009-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per electrophysiology examination of incision on (b)(6) 2017 site suggestive potential seroma versus hematoma.Upon physical evaluation, it is soft to the touch, without surrounding erythema, or increased pain from post procedural baseline.Additionally, there has been no reported fevers or chills, and white blood cell count has remained stable.Doppler scan has ruled out deep vein thrombosis.Patient reports no missed dosing of keflex post procedure.Patient was recommended to increase antibiotic regimen of keflex 500mg tid from 5 to 7 days.The instructions for use for the cangaroo ecm envelope lists 'seroma' under potential complications associated with the use of the device.The device remains implanted and no further events have been reported.A review of manufacturing lot history record shows that the reported lot was released to distribution on 1/19/2017 having met all manufacturing and quality release requirements including product sterility testing.There were no manufacturing deviations or non-conformances associated with the production of this lot.
Event or Problem Description
It was reported that a (b)(6) year old female with a history of malignancy and pocket re-entry (within 2 weeks of initial implant), left bundle branch block and chronic obstructive pulmonary disease had a dual chamber pacemaker implanted on (b)(6) 2017 using a cormatrix cangaroo ecm envelope (cmcv-009-med lot # m16n1322), hydrated with vancomycin and gentamycin.Patient required an rv lead revision due to dislodgement on (b)(6) 2017.On (b)(6) 2017 subject presented at the emergency department and was diagnosed with seroma/hematoma at the pacemaker site.This site investigator determined that the event was possibly related to cangaroo ecm and probably related to the procedure.The probable cause of the event was listed as, "seroma/hematoma at pacemaker site".

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• MDR Report Key: 6565141
• Report Number: 3005619880-2017-00017
• Device Sequence Number: 13640633
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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: 12/13/2019
• Device Model Number: CMCV-009-MED
• Device Lot Number: M16N1322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUAL CHAMBER PACEMAKER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 71