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

Catalog Number	9-PLUG-014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Literature article: intermediate and long-term follow-up of transcatheter closure of congenital coronary cameral fistulas in infants and children: experience from a single center as reported through a article review a 2.25-year-old patient with a coronary cameral fistula and coronary artery aneurysm.It was reported that a 14mm amplatzer vascular plug was chosen for implant to occlude a coronary cameral fistula.It was reported 3 months post-procedure, a large residual shunt was noted.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 available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, ¿intermediate and long-term follow-up of transcatheter closure of congenital coronary cameral fistulas in infants and children: experience from a single center¿, was reviewed.The article presented a case study of a 2.25-year-old, 10kg patient with a coronary cameral fistula and coronary artery aneurysm.It was reported that on an unknown date, a 14mm amplatzer vascular plug was chosen for implant to occlude a coronary cameral fistula.It was reported 3 months post-procedure, a large residual shunt was noted.There was no treatment reported.The article concluded that tcc of ccfs in infants and children appears to be effective and is associated with a relatively low complication rate.Large ccfs and giant coronary artery aneurysms (caas) represent a higher risk of both acute and intermediate and long-term adverse events after closure.[the primary and corresponding author was zhiwei zhang, department of pediatric cardiology, guangdong cardiovascular institute, guangdong provincial people¿s hospital (guangdong academy of medical sciences), southern medical university, guangdong provincial key laboratory of south china structural heart disease, guangzhou, 510100, china, with corresponding email: drzhangzw@sohu.Com].

• Brand Name: AMPLATZER VASCULAR PLUG
• 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: 17908708
• Report Number: 2135147-2023-04441
• Device Sequence Number: 20718601
• Product Code: KRD
• UDI-Device Identifier: 00811806011493
• UDI-Public: 00811806011493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031810
• 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): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PLUG-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/10/2023
• 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
• Patient Age: 2 YR
• Patient Sex: Unknown
• Patient Weight: 10 KG