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

Model Number	9-PDA2-06-06
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem 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.
Additional 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
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10763773
• Report Number: 2135147-2020-00457
• Device Sequence Number: 790848
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• 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
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 11/10/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/01/2020; 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 73