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

Model Number 9-PDA2AS-04-04-L

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 4x4 amplatzer duct occluder ii was selected for implant.While positioning the device, the delivery cable detached 12cm from the distal end.The connecting cable was removed and the detached portion was removed successfully with forceps.The procedure was successfully completed with another amplatzer duct occluder ii.

Manufacturer Narrative

The report of a fractured delivery wire was confirmed.The delivery wire was fractured through a spot weld just proximal to the distal coil.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The fracture appeared to be a tensile failure with no evidence of a torsional component.As a result of this finding, abbott is performing further investigation.

Manufacturer Narrative

Correction:the report of a fractured delivery wire was confirmed.The delivery wire was fractured through a spot weld just proximal to the distal coil.Videos of the procedure were received and analyzed by an abbott director of medical affairs.The anatomy and curvature of the delivery wire at the moment of the fracture were consistent with an interrupted ivc with azygous continuation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.A historical incident review, beginning 1jan2015 of all devices which use this component, found no similar incidents or nonconformances had occurred.Sem imaging determined the fracture appeared to be a tensile failure with no evidence of a torsional component.The degree of curvature required to traverse the interrupted ivc resulted in additional stress and was a likely contributing factor to the fractured delivery wire.Though there was no conclusive evidence of an underlying manufacturing or design related issue, abbott is performing further investigation.

Manufacturer Narrative

Correction: d2.

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9368942
• MDR Text Key: 168182137
• Report Number: 2135147-2019-00412
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 9-PDA2AS-04-04-L
• Device Catalogue Number: 9-PDA2AS-04-04-L
• Device Lot Number: 6689440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• 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
• Patient Outcome(s): Required Intervention