MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER® DUCT OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Difficult to Insert (1316); Migration or Expulsion of Device (1395); Off-Label Use (1494); Human-Device Interface Problem (2949)

Patient Problems Air Embolism (1697); Hemolysis (1886); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Cardiac Perforation (2513); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

In an research article perivalvular leak/residual leak, hemolysis, bleeding, blood transfusion, retroperitoneal hemorrhage, device advancement difficulty, perforations, tamponade, dissection of the left atrium, dislodged to the left atrium, coronary air embolism, bradycardia, ventricular tachyarrhythmia, leaflet entrapment and valve disc motion interference were reported.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.Please note, per instructions for use, artmt100092302 rev.A, "the amplatzer¿ duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).".

Event Description

The article, "long-term outcomes of catheter-based intervention for clinically significant paravalvular leak", was reviewed.This research article is a prospective single center experience to assess the long-term outcomes of patients undergoing percutaneous paravalvular leak (pvl) closure.Amplatzer¿ duct occluder (ado), the amplatzer¿ vascular plug ii (avp ii), the amplatzer¿ vascular plug iii (avp iii) (all abbott) the occlutech® pld occluder (occlutech gmbh, jena, germany) and the nit-occlud®coils (pfm medical, cologne, germany) were associated with the study.The article concluded that for patients who are deemed intermediate- to high-risk for repeat surgery, transcatheter pvl closure shows reasonable clinical success rates, with a significant improvement in symptoms, and a relatively low rate of periprocedural complications.[the primary and correspondence author of the article is leor perl, md, department of cardiology, rabin medical center, beilinson hospital, 39 jabotinsky st, petach tikva, 4941492, israel, with corresponding email: leorperl@gmail.Com].Related manufacturer report number: 2135147-2021-00547, 2135147-2021-00549.

• Brand Name: AMPLATZER® DUCT OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12969313
• MDR Text Key: 284719081
• Report Number: 2135147-2021-00548
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male