MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 9-AVP2-014

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 12mm amplatzer vascular plug ii (8855126) was chosen for implant using a 6f non-abbott delivery sheath.A 5f non-abbott secondary sheath was inserted into the 6f non-abbott sheath as a secondary catheter.A 0.035" guidewire was advanced into the pulmonary artery side of the patient ductus arteriosus and the 6f non-abbott sheath was delivered.After the 12mm plug was deployed, it was confirmed that the device was too small for the defect and the device was removed from patient body.The 12mm plug was never released from the delivery cable while inside the patient.A 14mm amplatzer vascular plug was then chosen for implant.When the 14mm device was deployed inside the patient, the third disc of the device appeared to be expanded.The device was then removed, when it was deployed outside the patient body, the third disc shape was different than usual.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 14mm amplatzer vascular plug ii (8840855) was then chosen for implant using the same 6f non-abbott delivery sheath to replace the deformed device.The replacement device (8840855) was successfully implanted without any problems.There was no health impact has been reported.

Manufacturer Narrative

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

Manufacturer Narrative

An event of device deformity during deployment was reported.A returned device assessment could not be performed as the device was not returned for analysis.Please note per the instructions for use, the recommended size delivery system for use with a 14mm amplatzer vascular plug ii is an 8f.A 6f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a smaller sheath may influence deformations of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 16906549
• MDR Text Key: 314950517
• Report Number: 2135147-2023-02034
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071699
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 8836545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Female