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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VSD OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER
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AGA MEDICAL CORPORATION AMPLATZER VSD OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Device Problem Biocompatibility (2886)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported through a research article identifying both a muscular ventricular septal defect(mvsd) occluder and a perimembranous ventricular septal defect (pmvsd) occluder that may be related to significant early post-procedural complications.Details are listed in the attached article, titled "transcatheter closure of perimembranous ventricular septal defects early and long-term results".Between january 1999 and june 2006, data was collected on 104 patients who underwent transcatheter closure of a perimembranous ventricular septal defect(pmvsd) under general anesthesia with orotracheal intubation and 100 iu/kg of heparin and antibiotics given intravenously.The patient's general characteristics are reported 58 females, 46 males with a median age of 14 yrs and a median weight of 26.5kg.In one case a (b)(6) female (b)(6) experienced a femoral arterial thrombosis and thrombolysis with recombinant tissue plasminogen activator was successful in treating the patient.
 
Manufacturer Narrative
As reported in a research article, one patient had a femoral arterial thrombosis and thrombolysis after implant with an amplatzer vsd occluder.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported through a research article identifying both a muscular ventricular septal defect(mvsd) occluder and a perimembranous ventricular septal defect (pmvsd) occluder that may be related to significant post-procedural complications.Details are listed in the attached article, titled "transcatheter closure of perimembranous ventricular septal defects early and long-term results".This research article is a prospective single center experience to evaluate safety, efficacy and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmvsd).Devices that were associated with this study were muscular ventricular septal defect (mvsd) occluders and perimembranous ventricular septal defect (pmvsd) occluders.Between january 1999 and june 2006, data was collected on 104 patients who underwent transcatheter closure of a pmvsd under general anesthesia with orotracheal intubation and 100 iu/kg of heparin and antibiotics given intravenously.The patient's general characteristics are reported 58 females, 46 males with a median age of 14 yrs and a median weight of 26.5kg.In one case a 1 year old female (7.5kg) experienced a femoral arterial thrombosis and thrombolysis with recombinant tissue plasminogen activator was successful in treating the patient.There is no allegation of malfunction of both the pmvsd and msvd occluder devices.The primary author of the article is gianfranco butera, md, department of pediatric cardiology, irccs policlinico san donato, piazza edmondo malan, 2.San donato milanese, italy 20097 with the corresponding email: gianfra.But@lycos.Com.
 
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Brand Name
AMPLATZER VSD OCCLUDER (UNKNOWN)
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
MDR Report Key10084026
MDR Text Key192153421
Report Number2135147-2020-00210
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 YR
Patient Weight7
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