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

Model Number	9-PDAP-04-04-L
Medical Device Problem Codes	Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 4mm by 4mm amplatzer piccolo occluder was selected for implant in a 44 day old, 1.2 kg patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter 2.8mm, pda diameter at aortic ampulla 3.2mm, pda length 13mm.The device was successfully implanted with accurate intraductal placement and no impingement of aortic flow.On (b)(6) 2022, it was revealed on echocardiography that the device had migrated and was protruding into the descending aorta with prominent gradient measurements.The physician attempted to snare the device from the pulmonary artery (pa) but was unsuccessful.The device was required to be retrieved surgically, and the patient's pda was surgically ligated.The patient recovered from surgery and was extubated within 72 hours.There was no implication of permanent impairment or damage, and inversely, the team feels closure of the pda was helpful in pulmonary function.The patient status is stable.No additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
An event of migration of the 4mm by 4mm amplatzer piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, the correct size piccolo occluder for the measurements provided was 4mm by 4mm.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13457579
• Report Number: 2135147-2022-00058
• Device Sequence Number: 12208966
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7060635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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: 44 DA
• Patient Sex: Male
• Patient Weight: 1 KG