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

Model Number	9-AVP2-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Aneurysm (1708); Atrial Fibrillation (1729)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer vascular plug ii implant were reported in a research article in a subject population with multiple co-morbidities including hypertension, atrial fibrillation, and chronic heart disease.The complication of hematoma was reported; the complication is anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
The article, ¿internal iliac artery aneurysm ruptures with no visualized endoleak 2 years after endovascular repair¿, was reviewed.The research article presents a case study of a 83-year-old male presented with right iia aneurysm of 36 mm in diameter on an unknown date.His comorbidities included hypertension, atrial fibrillation, and chronic heart disease, and had taken warfarin.Underwent endovascular repair for the treatment of iia aneurysm, including insertion of a stent graft from the common to the external iliac artery following embolization of the right iia.No endoleak was seen on computed tomography (ct) 5 days after the endovascular repair.Two years after the first treatment, ct revealed that the aneurysm gradually expanded to a diameter of 50 mm without evidence of endoleak.Angiography showed no endoleak.Considering advanced age and comorbidities, further intervention was not offered at that time due to no findings of endoleak.One month after, the patient took a blood test regularly because of the administration of the oral intake of warfarin.Although the patient had no symptoms such as abdominal or back pain, anemia was detected via the blood test.Hemoglobin level dropped from 10.3 to 7.5 g/dl, and prothrombin time¿international normalized ratio (pt-inr) was markedly elevated to 3.51.Serum creatinine level was 1.10 mg/dl, and no data were suggesting disseminated intravascular coagulation.Upper gastrointestinal endoscopy showed no findings of gastrointestinal bleeding.The patient underwent a ct examination to explore the cause of anemia.Although ct showed a hematoma around the right iia aneurysm, there are no findings of endoleak.Vital signs were stable (blood pressure, 102/64 mmhg; heart rate, 68 beats per minute).Elective open surgery was performed via retroperitoneal approach under general anesthesia.A ruptured hole was detected at the anterior of the right iia aneurysm.Common and external iliac arteries were not clamped.The aneurysm sac was incised, and the intraluminal thrombus was removed.There were no findings of obvious endoleak.A fresh hematoma around the aneurysm was removed as much as possible.The amplatzer vascular plug ii, which had been deployed to right iia in previous endovascular treatment, was removed, and backflow from iia was detected.Distal iia was sutured and aneurysm sac was sutured tightly.Patient anemia was improved, and ct showed no expansion of hematoma after the open surgery.The article concluded that a rare case of iia aneurysm rupture due to an endotension after endovascular repair.Aneurysm sac expansion may lead to rupture despite no finding of endoleak: therefore, close follow-up or re-intervention should be considered.Tight embolization such as amplatzer vascular plug (avp) with coils or embolization of each branch of iia may prevent endotension in the same case.The author and corresponding author of this article is ayumi harada, md, koichi morisaki, md, phd, department of surgery and science, graduate school of medical and sciences, kyushu university, 3-1-1 maidashi, higashi-ku, fukuoka, fu-kuoka 4812-8582, japan.

• 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: 14637343
• Report Number: 2135147-2022-00354
• Device Sequence Number: 5574896
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• 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
• Report Date (Section B): 06/08/2022

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-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/08/2022
• 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: 83 YR
• Patient Sex: Male