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

Model Number VASCULAR PLUG 4

Device Problems Difficult to Fold, Unfold or Collapse (1254); Use of Device Problem (1670)

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

Event Date 07/05/2022

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) 2022, an 8mm amplatzer vascular plug iv was chosen for implant in the pulmonary artery.During the procedure, it was noted that the plug had elongated longer than anticipated due to vessel conformity.When positioning the device, the plug was elongating into a neighboring pulmonary branch.The device was removed prior to release from the delivery cable.For replacement, coils were implanted instead.There was no clinically significant delay in procedure and no adverse patient effects.It was noted that the patient had tortuous anatomy.The patient is discharged.

Manufacturer Narrative

An event of device deformation was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.H6 medical device problem code: code 1254 removed and code 1670 added.

• Brand Name: AMPLATZER VASCULAR PLUG IV
• 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: 15123384
• MDR Text Key: 304529914
• Report Number: 2135147-2022-00591
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113658
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 8159680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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