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

Model Number 9-VSD-MUSC-008

Device Problems Pacing Problem (1439); Device Operates Differently Than Expected (2913)

Patient Problem Complete Heart Block (2627)

Event Date 01/15/2015

Event Type  Injury  

Event Description

Upon delivery of an 8mm amplatzer muscular vsd occluder (muscvsd), the patient went into heart block and required temporary pacing.After multiple attempts to wean the temporary pacemaker were unsuccessful, the physician removed the muscvsd percutaneously and transferred the patient to the operating room.

Manufacturer Narrative

(b)(4).

Event Description

Upon delivery of an 8mm amplatzer muscular vsd occluder (muscvsd), the patient developed heart block.Attempts to wean the patient from the temporary pacemaker were unsuccessful and the physician elected to remove the muscvsd.The patient was transferred to the operating room.The defect was surgically repaired.

• Brand Name: AMPLATZER MUSCULAR VSD 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 Key: 4464256
• MDR Text Key: 5321177
• Report Number: 2135147-2015-00006
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: 9-VSD-MUSC-008
• Device Catalogue Number: 9-VSD-MUSC-008
• Device Lot Number: 4834929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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: 3 MO
• Patient Weight: 5