MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® CARDIAC PLUG (UNKNOWN); CARDIAC OCCLUDER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the amplatzer cardiac plugs were not returned for evaluation.A review of the device history record could not be completed because the batch/lot numbers were not provided.There was no evidence to suggest there was an intrinsic defect in the devices, and the cause for the reported event remains unknown.

Event Description

The following information is from an accepted manuscript (accepted date: 13 july 2017) to appear in the international journal of cardiology, titled, "left atrial appendage closure using amplatzer devices: a large, multicenter, italian registry".The aim of this retrospective study was to assess the feasibility, safety and efficacy of laao by using amplatzer¿ devices in a large, multicenter, single-nation cohort of nvaf patients at high-risk of stroke and bleeding, untreated with oac.The relationship between caseloads and the feasibility and safety of laao with amplatzer¿ devices was also explored.This was a retrospective multicenter registry, conducted in 15 italian centers and enrolled 613 consecutive nvaf (non-valvular atrial fibrillation) patients undergoing laao using amplatzer¿ devices from december 2008 to april 2015.Results: amplatzer¿ devices were successfully implanted in 95.4% of cases.Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%).At a mean follow-up of 20 months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and tia of 66% compared with the risk based expectation.Among the 218 patients undergoing transesophageal echocardiography at 6 months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.Conclusions: in this large, multicenter, single-nation study, laao with the amplatzer¿ devices showed high procedural success, early safety and mid-term efficacy for the prevention of nvaf-related thromboembolism.

• Brand Name: AMPLATZER® CARDIAC PLUG (UNKNOWN)
• Type of Device: CARDIAC OCCLUDER
• 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 Key: 6798745
• MDR Text Key: 82842203
• Report Number: 2135147-2017-00091
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• 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): Hospitalization; Required Intervention