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

Model Number 9-ASD-MF-025

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

After successful placement of the 25 mm amplatzer cribriform occluder (aco), a pressure drop was noted and a tee confirmed an effusion.A surgical repair of a cardiac wall perforation was required; however, the aco remains implanted and is in a stable position.Per report, the exact cause of the perforation is unknown; however, the user believes it to be the result of either the multipurpose cath, 0.035 super stiff guidewire (manufacturer unknown), or the 9f amplatzer torque delivery sheath or dilator.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER CRIBRIFORM 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 ; 6517565400
• MDR Report Key: 5677241
• MDR Text Key: 45858365
• Report Number: 2135147-2016-00058
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 4897955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR