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

Model Number 9-AVP2-008

Device Problems Difficult to Fold, Unfold or Collapse (1254); Fracture (1260)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, an 8mm amplatzer vascular plug ii was chosen for implant using a non-abbott delivery system.The goal of the procedure was persistent ductus arteriosus occlusion.The device was prepared per the instructions for use (ifu) and washed with saline solution.While attempting to position the plug, it was retracted and redeployed three times due to the instability of the central disc, which caused difficulty positioning the device.The device remained attached to the delivery cable and was removed from the patient.After removal, it was observed that there was a hole through the nitinol mesh in the central disc of the device.A 10mm amplatzer vascular plug ii was then chosen for implant to replace the 8mm device.The replacement device was successfully implanted, and the procedure was concluded.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was reported as stable.

Manufacturer Narrative

An event of difficulty positioning of the device, device not taking proper shape and a hole in nitinol mesh in the central disc of device was reported.The investigation confirmed the device met functional and visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Images from field appeared to show an avp device connected to the delivery cable.A hole was seen in the central disc of the plug in one of the images.The cause of the reported event of hole in device is the result of the manufacturing process and is consistent with a forming hole which is considered to be a normal and acceptable characteristic of the device.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on 13 march 2023, an 8mm amplatzer vascular plug ii was chosen for implant using a non-abbott delivery system.The goal of the procedure was persistent ductus arteriosus occlusion.The device was prepared per the instructions for use (ifu) and washed with saline solution.While attempting to position the plug, it was retracted and redeployed three times due to the instability of the central disc, which caused difficulty positioning the device.The device remained attached to the delivery cable and was removed from the patient.After removal, it was observed that there was a hole through the nitinol mesh in the central disc of the device.A 10mm amplatzer vascular plug ii was then chosen for implant to replace the 8mm device.The replacement device was successfully implanted, and the procedure was concluded.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that the device was checked prior to implant.When attempting to implant the device, the central disc was not taking the correct shape.

• 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: 16691804
• MDR Text Key: 312943783
• Report Number: 2135147-2023-01505
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 8584313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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