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

Model Number	9-AVP2-012
Medical Device Problem Codes	Off-Label Use (1494); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 a 12mm amplatzer vascular plug ii was selected for an implant.During the procedure after opening and flushing the device the physician notice a hole on the device.The physician continue with the procedure and implanted the device in the patent ductus arteriosus (pda).Post deployment there was leakage on plug.Device was removed from the patient and a new amplatzer vascular plug ii was implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a hole in the device was reported.A returned device inspection, to rule out any device-related causes, 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.
Additional Manufacturer Narrative
An event of a hole being present in the device was confirmed.A hole is present in the central disc of amplatzer vascular plug ii; the forming hole is a result of the manufacturing process and does not impact the function of the device.The investigation confirmed the device met 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 event 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 regards to design, manufacture, or labeling.Please note, as per instruction for use,the amplatzer¿ vascular plug and amplatzer¿ vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature.", "warnings: the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established."h6.Medical device problem code 1506 product quality problem removed.
Event or Problem Description
N/a.

• Brand Name: AMPLATZER VASCULAR PLUG II
• 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: 15420390
• Report Number: 2135147-2022-01202
• Device Sequence Number: 2544961
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K071699
• 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,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 05/31/2026
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 8023013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 01/17/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/20/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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 Age: 3 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American