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

Model Number	9-AVP2-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An article from the japanese college of angiology reported a case of a 80 years old female who had aortic dissection with stanford b type and was being treated conservatively.After 17 years since the initial occurrence, marked enlargement of false lumen revealed via computerized tomography (ct) scan.It was decided that the primary entry for 15mm was required to be sealed by thoracic endovascular aneurysm repair (tevar) navion stent graft was implanted from zone 4 to the area of sub-diaphragmatic.Regurgitation from re-entry location to false lumen at the central of descending aorta was detected by a postoperative angiography.Candy-plug was created and inserted in not dilatated false lumen at the level of celiac artery to superior mesenteric artery.A-non-abbott plug was made as following step.A center of a 36mm excluder aortic extender (mfr: gore) was sewed and shortened.A 16mm amplatzer vascular plug ii was inserted into the non-abbott plug and embolization coil was dwelled into the vascular plug and implanted around the avpii as well.It was confirmed that flow into the false lumen disappeared postoperative ct.However, diameter of aneurysm at the distal of descending aorta was becoming enlarged which was confirmed by ct at 6 month after the surgery.It was diagnosed as d-sine (distal stent graft-induced new entry).C-tag stent graft (mfr gore) was implanted from inside of navion to just above of sma.Furthermore, a non-abbott device was additionally implanted until under renal artery in order not to recur d-sine.The physician alleged that d-sine might have occurred because the candy plug had been implanted more distal portion over the distal edge of the stent graft, so stress between the candy-plug and the stent graft implanted in the true lumen became imbalance.No further information is available.[the primary author and corresponding author of this article is kamiyama, takuro md , 6-7 izumicho kagoshima, 892-0822 japan].
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 distal stent graft-induced new entry was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.The physician thought that the distal stent graft-induced new entry might have occurred because the candy plug had been implanted more distal portion over the distal edge of the stent graft, so stress between the candy-plug and the stent graft implanted in the true lumen was imbalanced.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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: 15849867
• Report Number: 2135147-2022-02187
• Device Sequence Number: 12066216
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/31/2023
• 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: 80 YR
• Patient Sex: Female