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

Model Number	9-AVP2-012
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Angina (1710)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
An article from the 58th annual meeting of japanese society of pediatric cardiology and cardiac surgery conference, abstract p.I-p2-6-02; report a case of 4yrs and 3 month old male infant (height 107cm, weight 18.1kg) with congenital coronary artery fistula diagnosed with cardiac murmur since birth.At one year and 3 month old, coronary angiography was conducted.Qp/qs=1.9, the right coronary artery (rca) and left circumflex artery (lcx) flowed into the same opening in the posterior right ventricle.It was finally diagnosed as distal bilateral coronary arteriovenous fistula.The male infant had anterior chest pain since age 3.It was decided that the inflow portion of right ventricle was required to be embolized.A 5f non-abbott device was delivered and passed through the narrowest area of rca.A 12mm amplatzer vascular plug 2 was attempted to be implanted, the plug fell off on multiple attempts.It was found that the non-abbott device sheath did not actually crossed over the narrowest area and made rca compressed.The 12mm amplatzer vascular plug 2 was placed with unknown size amplatzer vascular plug 2 which was inserted and deployed in the vessel by antegrade approach.After the procedure, neither electrocardiogram change nor coronary artery obstruction was confirmed.[the primary author and corresponding author of this article is jun muneuchi , md ,1 chome-8-1 kishinoura, yahatanishi ward, kitakyushu, fukuoka 806-8501, japan].
Event or Problem Description
N/a.
Additional Manufacturer Narrative
As reported through a research article, the amplatzer plug "fell off even multiple attempts".Information from the field indicated that it was found that the competitor's sheath did not actually cross over the narrowest area and made rca compressed.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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15617450
• Report Number: 2135147-2022-01669
• Device Sequence Number: 14942625
• 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,Followup
• Report Date (Section B): 12/28/2022

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?: Yes
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 18 KG