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Model Number CMCV-009-LRG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930)
Event Date 12/03/2021
Event Type  Injury  
Event Description
Clinical research manager of cangaroo study reported patient adverse event as follows: on (b)(6) 2021, patient received de novo implant of a biventricular pacemaker automatic implantable cardioverter defibrillator (biv aicd) with cangaroo envelope (model cmcv-009-lrg, lot number m21e1177636).On follow-up visit (b)(6) 2022, patient had signs of infection at implant site and was admitted to the hospital.Device explanted on (b)(6) 2022 and patient started on cephalexin.Physician reported that patient had a wound dehiscence which resulted in pocket infection.Physician reported that event was "probably related" to the implant procedure.Patient is male, (b)(6).
Manufacturer Narrative
No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on (b)(6) 2022, showing that all units were quality released on (b)(6)2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21c1120 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on (b)(6) 2021 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, "infection" is listed as a potential complication associated with this procedure and device usage.Although the exact cause of the reported issues cannot be conclusively determined, the root cause of the wound dehiscence, and resulting infection, is likely procedure related and could occur regardless of the use of the aziyo device.The aziyo device was sterilized with ethylene oxide gas and was supplied to the end user as a sterile device.The wound dehiscence is possibly related to the surgical technique of the surgeon--either in pocket sizing to accommodate all parts of the implant or in surgical closure of the implant site.It is also possibly related to the post-op care of the implant site provided by the patient.The presence of a dehiscence in the suture line would make the possibility of pocket infection extremely likely, as there is the creation of a communication from outside the patient into the wound pocket.Wound dehiscence and post-operative infection are both known potential complications of any surgical procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event Description
After initial filing of this mdr, it was reported that the patient developed a small hematoma on (b)(6) 2021, prior to the previously reported dehiscence/infection.It was described as clean, dry, and intact, likely the result of the surgical procedure, and unrelated to the implant of the aziyo device.No treatment was prescribed.
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Brand Name
Type of Device
Manufacturer (Section D)
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer (Section G)
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer Contact
michael hennick
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key13443917
MDR Text Key288817785
Report Number3005619880-2022-00003
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/29/2023
Device Model NumberCMCV-009-LRG
Device Lot NumberM21E1177
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age58 YR
Patient SexMale