MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA-009

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Connection Problem (2900)

Patient Problem Embolism (1829)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

An event of a device premature release with subsequent embolization when attempting to retract the device after it failed to fully occlude the defect was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Please note, per the 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)," and is not indicated for closure of a ruptured sinus of valsalva aneurysm.This may have contributed to the reported residual shunt.The cause of the device release and subsequent embolization could not be conclusively determined.

Event Description

Reference manufacturing report number: 2135147-2020-00140.On (b)(6) 2020, a 16-14 amplatzer duct occluder was selected for implant for a sinus valsalva aneurysm with an 8f/45 torqvue delivery system.After deploying the device and prior to release, the physician was not satisfied with the positioning of the device.The physician attempted to retract the device, but it prematurely released from the delivery system and embolized to the pulmonary artery.A 10f/45 torqvue delivery system was used to retrieve the device without success.The patient was stable when referred to surgery to retrieve the device and close the defect.There were no patient consequences.No additional information.

Manufacturer Narrative

Correction information for d2 additional information for g4, g7, h2, h10.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9900927
• MDR Text Key: 186212528
• Report Number: 2135147-2020-00139
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 9-PDA-009
• Device Lot Number: 5993660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER TORQVUE DELIVERY SYSTEM.
• Patient Outcome(s): Required Intervention