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	Arrhythmia (1721); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature article: a rare case of transcatheter closure of both inlet and outlet of a left coronary artery-to-left ventricular fistula with giant coronary artery aneurysm.As reported through a literature review a patient who had a amplatzer duct occluder ii and amplatzer vascular plug ii (avpii) implanted at the outlet and inlet of fistula.After releasing the avpii, it showed that distal lad was occluded.The patient was under conservatives treatment instead of surgical removal of the device.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, "a rare case of transcatheter closure of both inlet and outlet of a left coronary artery-to-left ventricular fistula with giant coronary artery aneurysm", was reviewed.This research article reported a case study on a 8 year old patient presented to the hospital due to continuous cardiac murmur.On admission, the patient's temperature was 36.8°c, and her blood pressure was 100/55 mmhg.The patient's heart rate was 90 bpm.Oxygen saturation was 100%.Continuous murmur could be heard at the 4th¿5th intercostal space near the left sternal border.Electrocardiography (ecg) showed normal sinus rhythm.Transthoracic echocardiography (tte) revealed a severe dilation of the lca ostium with a giant aneurysmal coronary artery located above the intraventricular septum (ivs).The coronary artery was draining into lv cavity through an orifice with diameter of 4.0 mm.Color doppler flow imaging detected a continuous double-phase turbulent spectrum at the orifice, suggesting the presence of an lca-to-lv fistula.Since no sign of left ventricular overload was present, the shunt was considered small degree.Three-dimensional computed tomography (3d-ct) scan confirmed that the fistula was proximal type, originating from anterior interventricular branch of lca and draining into lv cavity with giant caa of 41 mm × 28 mm in diameter.Compression of both lv and right ventricular outflow tract (rvot) by the giant caa was seen.It was decided to perform transcatheter closure of both the inlet and outlet of the fistula for the patient.During the procedure, coronary angiography further confirmed the abnormalities in these structures and excluded any other coronary artery lesions.The diameters at the inlet and outlet of fistula were 7.2 and 3.5 mm, respectively.An arterial-arterial loop was created, and an unknown 6-fr sheath was delivered anterogradely through the aneurysm and reached to the drainage site.A 04-04 mm amplatzer duct occluder ii and a 12 mm amplatzer vascular plug ii were deployed at the outlet and inlet of fistula, respectively.After releasing the avp ii, repeated coronary angiography showed that distal lad was occluded.However, there was no st-t changes on 12-lead ecg during the procedure.Since the patient was at high risk of ventricular septal hematoma and left ventricular function impairment after incision of the aneurysm, it was decided to keep the patient under conservative treatment instead of surgical removal of the device and ended the procedure.At postoperative day 1, the patient experienced elevation of cardiac troponin t (tnt, peak of 448 pg/ml; normal values < 14 pg/ml) and creatine kinase-mb (ck-mb, peak of 41.9 u/l; normal values < 24 u/l).Although no elevation of st segment or st-t changes was detected in ecg, the patient's 24-h holter monitoring showed period of junctional escape rhythm and aberrant ventricular conduction, indicating potential myocardial ischemia.Tte demonstrated both devices were well located, without apparent residual shunt (figs.5a and 5b).Thrombus formation was detected within the caa, and lca ostium was still dilated.The patient was given dual antiplatelet therapy with aspirin (5 mg/kg) and clopidogrel (1 mg/kg).The remaining postoperative course was uneventful.The patient's ecg returned to normal sinus rhythm at postoperative day 2, and level of ck-mb returned to normal level (21 u/l).The patient recovered well and was discharged at postoperative day 7 post procedure without complications.The patient was prescribed with dual antiplatelet therapy for a total of 6 months.Follow-up tte at 2 years showed shrinkage size of caa, and the two devices were in proper position without residual shunt.The diameter of lca ostium has significantly reduced.Lv function was normal (lv ejection fraction 62%), without signs of regional wall motion abnormality.Follow-up ecg at 2 years showed normal sinus rhythm.The patient was in good clinical conditions, without cardiovascular symptoms or signs of late complications such as myocardial infarction or thromboembolism.[the primary and correspondence author is zhiwei zhang, md, department of pediatric cardiology, guangdong cardiovascular institute, guangdong provincial people¿s hospital, guangdong academy of medical sciences, guangdong provincial key laboratory of south china structural heart disease, guangzhou, china, with email: drzhangzw@sohu.Com].

• 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: 17263133
• Report Number: 2135147-2023-02897
• Device Sequence Number: 6058889
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/05/2023

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-AVP2-012
• 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: 06/20/2023
• Initial Report FDA Received Date: 07/05/2023
• 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: 8 YR
• Patient Sex: Female