MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA2-06-06
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, ¿percutaneous closure of severe calcified patent ductus arteriosus with two amplatzer devices¿, was reviewed.The article presents a case study of an 89-year-old woman with patent ductus arteriosus (pda) with severe calcification.It was reported on an unknown date that a 6-6mm amplatzer duct occluder ii was chosen for implant to occlude a patient¿s pda that measured 6mm in diameter and 14mm for ductus length.After the 6-6mm amplatzer duct occluder ii was implanted, it was seen via angiography there was a residual shunt through the pda.The physician released the occluder hoping the residual shunt would disappear due to endothelialization.It was later reported a few months later on an unknown date, follow up transthoracic echocardiography (tte) showed no improvement in the residual shunt and the patient symptoms worsened.A decision was made to implant a 14-10mm amplatzer vascular plug ii.After a successful implant, it was noted the residual shunt had disappeared.The article concluded that pda in elderly individuals commonly features severe calcification.However, severe calcification can prevent endothelialization due to lack of appropriate deployment.An additional avp ii could be helpful in case of closure difficulty by a single pda device.[(b)(6).].
Additional Manufacturer Narrative
Literature article: percutaneous closure of severe calcified patent ductus arteriosus with two amplatzer devices investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
As reported in a research article,percutaneous closure of severe calcified patent ductus arteriosus with two amplatzer devices.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device 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 DUCT OCCLUDER II
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 17499509
• Report Number: 2135147-2023-03497
• Device Sequence Number: 2442405
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• 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): 09/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDA2-06-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female