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

Model Number DUCT OCCLUDER II

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

It was reported a 3mm-4mm amplatzer duct occluder was selected for implant on (b)(6) 2022.During the procedure, difficulty was noted implanting the device into position.The device was re-sheathed and deployed 5 to 6 times.Ultimately the device presented with deformation.The device was removed and exchanged with a new 3mm-4mm amplatzer duct occluder, that was successfully implanted.It was noted that the difficulty with implant was due to the sheath angle and the patent ductus arteriosus (pda) anatomy.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

N/a.

Manufacturer Narrative

An event of difficulty implanting the device and device deformity was reported.A returned device 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 defined manufacturing specifications.Please note that per the instructions for use, "if the position of the device or conformance of the discs to the vessel walls is unsatisfactory: stabilize the delivery wire and re-advance the delivery catheter until the device is completely within the catheter.Reposition the device and deploy it again, or remove the device from the patient.The device may be repositioned and recaptured up to 3 times."h6.Medical device problem code - 2017 improper or incorrect procedure or method was added.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14819751
• MDR Text Key: 297188628
• Report Number: 2135147-2022-00435
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011172
• UDI-Public: 00811806011172
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: DUCT OCCLUDER II
• Device Catalogue Number: 9-PDA2-03-04
• Device Lot Number: 7022088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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