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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADMEDUS REGEN PTY LTD CARDIOCEL NEO; INTRACARDIAC PATCH

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ADMEDUS REGEN PTY LTD CARDIOCEL NEO; INTRACARDIAC PATCH Back to Search Results
Catalog Number UC0508N
Device Problem Insufficient Information (3190)
Patient Problem Stenosis (2263)
Event Date 04/22/2020
Event Type  Injury  
Event Description
Partial anomalous pulmonary venous return of the right-sided veins to the ivc (scimitar syndrome); intra-atrial baffle in (b)(6) 2020 with subsequent occlusion.Tissue thickened around patch.Revision in 2022 with re-implantation of vein which was small and scarred; subsequently re-occluded, unable to be recanalized with a cath, and awaiting decision on next steps.
 
Manufacturer Narrative
Review of batch record did not identify any deviations or errors.Investigation and interviews with clinicians have been scheduled.Adverse events associated with bioprosthetic pericardial patches that have been reported in the literature, have included flow obstruction.
 
Event Description
Partial anomalous pulmonary venous return of the right-sided veins to the ivc (scimitar syndrome); intra-atrial baffle in april 2020 with subsequent occlusion.Tissue thickened around patch.Revision in 2022 with re-implantation of vein which was small and scarred; subsequently re-occluded, unable to be recanalized with a cath, and awaiting decision on next steps.
 
Manufacturer Narrative
Review of batch record did not identify any deviations or errors.Investigation has been completed and interviews with clinicians have been performed.The events occurred in 7 patients out of 140 treated with cardiocel.A call with physicians occurred to discuss the procedure and their findings.It was noted the events happened in cases of pa repair.Batch record review determined that all products met acceptance criteria.There were no manufacturing changes during this time period to suggest a change on the product.While anteris continues to monitor, it appears at this time the event to be unlikely related to the product but rather associated with the complex intervention and challenges of vascular reconstruction in these young patients.
 
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Brand Name
CARDIOCEL NEO
Type of Device
INTRACARDIAC PATCH
Manufacturer (Section D)
ADMEDUS REGEN PTY LTD
26 harris road
malaga, western australia 6080 6080
AS  6080
Manufacturer (Section G)
ADMEDUS REGEN PTY LTD
26 harris road
malaga, western australia 6080
AS   6080
Manufacturer Contact
jim chapman
860 blue gentien road
suite 340
eagan, MN 55121
6514930606
MDR Report Key15738163
MDR Text Key303139556
Report Number3012664855-2022-00008
Device Sequence Number1
Product Code DXZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 02/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/02/2022
Device Catalogue NumberUC0508N
Device Lot NumberM19032-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2019
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) Hospitalization; Life Threatening;
Patient Age3 YR
Patient SexMale
Patient Weight11 KG
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