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

Model Number	9-AVP2-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of dyspnea was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Additional information was received for an event initially reported under related manufacturer report number: 2135147-2016-00100.According to the article "pulmonary arterial hypertension associated with congenital portosystemic shunts treated with transcatheter embolization and pulmonary vasodilators" (doi: 10.2169/internalmedicine.55.6557), a patient implanted with a 20mm amplatzer vascular plug ii (avpii) secondary to an intrapulmonary shunt reported dyspnea and was diagnosed with hepatopulmonary syndrome and portopulmonary hypertension caused by congenital portosystemic shunts.Approximately three months post-implant, the patient's symptoms worsened reportedly indicating that transcatheter embolization exacerbated her pulmonary arterial hypertension.The patient was placed on vasodilator therapy.Six months later, hypoxia remained and an improvement in symptoms was noted.Clinical site patient id: (b)(6).

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8423284
• Report Number: 2135147-2019-00072
• Device Sequence Number: 19281635
• Product Code: KRD
• UDI-Device Identifier: 00811806010434
• UDI-Public: 00811806010434
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 9-AVP2-020
• Device Lot Number: 4124215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: Required Intervention
• Patient Age: 57 YR