MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number CVD0097

Device Problem Human-Device Interface Problem (2949)

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, after implantation of an amplatzer device, the patient developed a tia.A residual shunt was also present.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined an initial review of complaints data was reviewed as a component of the complaint handling risk review per wi (b)(4).The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.

Event Description

It was reported in an article titled, "complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke" that on an unknown date, a cardioseal/starflex device was initially selected for implant.However, due to periprocedural complications, the device was removed.One month later, the patient was implanted with an amplatzer device.During the follow-up period, the patient developed a transient ischemic attack due to a residual shunt.No additional information was provided.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10003042
• MDR Text Key: 189842196
• Report Number: 2135147-2020-00179
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0097
• Device Catalogue Number: CVD0097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/27/2020
• 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): Life Threatening; Other; Required Intervention