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

Catalog Number UNK AMPLATZER DUCT OCCLUDER II

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article "a case of percutaneous closure of patent ductus arteriosus in an elderly patient with peculiar morphology due to two unsuccessful surgical patent ductus arteriosus closure" was reviewed.The research article presents a case study of an 82-year-old female with dyspnea on exertion, patent ductus arteriosus (pda), heart failure, pulmonary hypertension, liver failure.An amplatzer duct occluder ii was chosen to percutaneously close the pda defect.The pda had complicated morphology with a high degree of tortuosity.Upon implantation, it was noted that the patient morphology did not match the device well, and there was a residual leak around the device due to calcification.A non-abbott coil was used to help successfully close the defect.The primary author of the article is hidehiko hara, toho university medical center ohashi hospital.

Manufacturer Narrative

An event of residual shunt was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the root cause of the reported event could not be conclusively determined but the patient's tortuous anatomy and calcification may have contributed to the reported residual shunt.D4: the udi number is not known as the part and lot number were not provided.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: 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: 16618624
• MDR Text Key: 312072062
• Report Number: 2135147-2023-01352
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER DUCT OCCLUDER II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female