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

Model Number 9-PDA2-06-06

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 6x6mm amplatzer duct occluder ii (adoii) was selected for implant.During the procedure, prior to the deploy of the adoii, the non-abbott sheath got caught between two mitraclips that were implanted approximately 2 months ago.The occluder was intended for implant between the 2 clips; further described as a2p2.The non-abbott sheath was cut at the groin and the sheath and occluder remain in the anatomy of the patient, still caught within the clips.The physician reports no plans to remove either products.A clinically significant prolonged procedure delay was reported.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of a sheath being used to implant a amplatzer duct occluder 2 in between two mitraclips and the sheath and occluder being left in the patient was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, arten600038220 revision a "the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus".

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10763773
• MDR Text Key: 213918756
• Report Number: 2135147-2020-00457
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDA2-06-06
• Device Catalogue Number: 9-PDA2-06-06
• Device Lot Number: 7578528
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 73