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

Model Number	VASCULAR PLUG 4
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022 a 8mm amplatzer vascular plug 4 was selected for procedure.It was noted during procedure that the plug did not sufficiently embolize the patient's pulmonary artery, proximal to the descending aortic arch after being deployed.After 5 minutes of observing, it was noted that the contrast agent was still able to pass through the pulmonary artery.The pulmonary artery had a length of 16.8mm.The decision was made to remove the 8mm amplatzer vascular plug 4 and implant a new unknown device to complete the procedure.There were no adverse patient consequences reported.
Event or Problem Description
It was reported that on 03 november 2022, a 8mm amplatzer vascular plug 4 was selected for procedure.It was noted during procedure that the plug did not sufficiently embolize the patient's pulmonary artery, proximal to the descending aortic arch after being deployed.After 5 minutes of observing, it was noted that the contrast agent was still able to pass through the pulmonary artery.The pulmonary artery had a length of 16.8mm.The decision was made to remove the 8mm amplatzer vascular plug 4 and implant a new unknown device to complete the procedure.There were no adverse patient consequences reported.Subsequent to the previously filed report.Additional information was received and a correction needs to be made as there was no replacement device implanted in the patient.It was noted that the diameter of the patient's pulmonary artery was 6mm.The 8mm amplatzer vascular plug 4 had been sized according to the diameter of the patient's pulmonary artery.It was noted that after implant/release of the 8mm amplatzer vascular plug 4 there was a residual shunt present.The decision was made to snare the plug and use different unknown embolization material to complete the procedure the patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.There was no allegation of malfunction against the 8mm amplatzer vascular plug 4 or procedure.
Additional Manufacturer Narrative
An event of residual shunt was reported.The investigation confirmed the device met functional and dimensional 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.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG IV
• Common Device Name: 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: 15848803
• Report Number: 2135147-2022-02191
• Device Sequence Number: 6525157
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 8447849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown