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

Catalog Number	9-AVP2-008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, a patient had residual shunt after implant of an amplatzer vascular plug ii off-label in a patent ductus arteriosus.A larger device was implanted "additionally".A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, ¿a challenging interventional procedure: transcatheter closure of tubular patent ductus arteriosus in patients with pulmonary hypertension¿, was reviewed.The article presents a case study of an 5-month-old, 5kg patient with the following patent ductus arteriosus (pda) measurements: minimal ductus diameter = 5.2mm, ampulla diameter = 7.7mm, ductal length = 6.9mm.It was reported on an unknown date, a 8mm amplatzer vascular plug ii was chosen for implant to occlude a pda.After the device was implanted, it was noted there was a residual shunt.A decision was made to additionally implant a 10mm amplatzer vascular plug ii.The second device was implanted successfully.[the primary and corresponding author is ilker kemal yucel, department of pediatric cardiology, university of health sciences dr.Siyami ersek thoracic and cardiovascular surgery training and research hospital, istanbul, turkey, ilkerkemalyucel@yahoo.Com] periprocedural complications included residual shunt and surgical intervention.

• 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: 17541600
• Report Number: 2135147-2023-03534
• Device Sequence Number: 6535435
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-AVP2-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Unknown
• Patient Weight: 5 KG