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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; CARDIAC OCCLUSION DEVICE

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AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; CARDIAC OCCLUSION DEVICE Back to Search Results
Model Number 9-ASD-MF-030
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
During implant of a 30mm amplatzer cribriform occluder (aco, lot 5556170), the device could not be advanced through an 8f amplatzer torqvue 45 delivery system (dtv45) sheath.The dtv45 was replaced and a new dtv45 was used to deploy the original aco; however, the aco deformed mushroom-shaped in the left atrium.The aco was removed and a second 30mm aco (lot 5658352) was implanted and released; however, post-release the 30mm aco was found to be too small and was snared and removed.A 35mm aco was implanted successfully using a new delivery system.
 
Manufacturer Narrative
(b)(4).The results of this investigation confirmed the amplatzer cribriform occluder met all functional and dimensional specifications when analyzed at sjm.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the reported event remains unknown.
 
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Brand Name
AMPLATZER CRIBRIFORM OCCLUDER
Type of Device
CARDIAC OCCLUSION DEVICE
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6131507
MDR Text Key61019276
Report Number2135147-2016-00121
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000039/S013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2016
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
Device Operator Physician
Device Expiration Date08/31/2021
Device Model Number9-ASD-MF-030
Device Catalogue Number9-ASD-MF-030
Device Lot Number5658352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2016
Initial Date FDA Received11/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2016
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) Required Intervention;
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