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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD AMPLATZER P.I. MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE
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ST. JUDE MEDICAL CATD AMPLATZER P.I. MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE Back to Search Results
Model Number 9-VSDMUSCPI-016
Device Problem Material Erosion (1214)
Patient Problems Bacterial Infection (1735); Erosion (1750); Pseudoaneurysm (2605)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On an unknown date a 16mm amplatzer p.I.Muscular vsd occluder was used to close a large pseudo aneurysm caused by an lv rupture.The aneurysm was described as large and protruding from the patient's chest.The device was implanted using a direct apical puncture through the skin.The device sealed the aneurysm and it decreased in size.The patient was discharged.Later, the presented at the hospital with the device eroded through their skin.The device was noted to be visible in the infected wound.The patient was taken to an operating room where a surgeon cleaned and stitched the wound.The patient was reported to be recovering.
 
Manufacturer Narrative
An event of the device eroding through the patient's skin was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
On an unknown date a 16mm amplatzer p.I.Muscular vsd occluder was used to close a large pseudo aneurysm caused by an lv rupture.The aneurysm was described as large and protruding from the patient's chest.The device was implanted using a direct apical puncture through the skin.The device sealed the aneurysm and it decreased in size.The patient was discharged.Later, the presented at the hospital with the device eroded through their skin.The device was noted to be visible in the infected wound.The patient was taken to an operating room where a surgeon cleaned and stitched the wound.The patient was reported to be recovering.
 
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Brand Name
AMPLATZER P.I. MUSCULAR VSD OCCLUDER
Type of Device
CARDIAC OCCLUSION DEVICE
Manufacturer (Section D)
ST. JUDE MEDICAL CATD
4 robbins drive
westford MA 01886
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
pamela yip
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key9151795
MDR Text Key162951573
Report Number2135147-2019-00287
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9-VSDMUSCPI-016
Device Catalogue Number9-VSDMUSCPI-016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/07/2019
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age87 YR
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