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

Model Number	9-AVP2-006
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body Embolism (4439)
Date of Event	04/28/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
This report is being conservatively reported despite the patients declining prognosis and lack of viable therapeutic options as reported by the implanting physician.All effective treatment options were exhausted.Surgical intervention was a final attempt despite the patient not being a candidate for surgery.On (b)(6) 2021, a patient with a bad diagnosis and suffering from hemodynamic shock, renal failure and an impaired liver ran out of effective treatment options.As a result, surgery was performed and the patient was placed on pulmonary ventilation to help them endure the procedure.A 5/2 amplatzer piccolo occluder was selected for implant in a patent ductus arteriosus (pda) with the following dimensions: pda length of 6-7 mm and diameter at aortic ampulla of 4.8.During the implant procedure, the device was mis-sized and found to be occlusive on the left pulmonary artery resulting in cardiogenic block.The device was removed and another device was attempted.A 6 mm amplatzer vascular plug ii (avp2) was then used, despite not being a suitable size for the pda.Again the device was mis-sized as it wasn't able adapt to the size of the pda.The avp2 and the sheath were removed.A new sheath and new 6 mm avp2 were selected again in attempt to implant the device.The device was placed and released, but then migrated and embolized into the right pulmonary artery.Three different en-snare's were attempted to retrieve the embolized device, but were unsuccessful.The patient suffered a cardiac arrest and was brought to open heart surgery and the prosthesis was successfully recovered.There was a clinically significant delay in the procedure.The patient passed away (b)(6) 2021 due to cardiogenic shock consequent to the patient's severe comorbidities.According to the physician, there was no allegation of malfunction with the any of the abbott devices.The physician believed the cause of the embolized device was because the avp2 did not have a size suitable for the dimensions of the patient's persistent ductus arteriosus.The physician classified the patient's death as being related to the patient's comorbidities.Requested relevant tests (imaging), procedure notes and lab reports were requested but the site was unable to provide.No additional information provided.
Additional Manufacturer Narrative
An event of off-label device implant even though the patient was not a candidate for surgery, device embolism and patient death due to cardiogenic shock was reported.A more comprehensive assessment 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11894434
• Report Number: 2135147-2021-00208
• Device Sequence Number: 1388191
• Product Code: KRD
• UDI-Device Identifier: 00811806010366
• UDI-Public: 00811806010366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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 Expiration Date: 06/30/2024
• Device Model Number: 9-AVP2-006
• Device Catalogue Number: 9-AVP2-006
• Device Lot Number: 7107503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 1 MO
• Patient Weight: 2