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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6)2021, a 4mm by 2mm amplatzer piccolo occluder was implanted in a 3-week-old, 800g patient to close a patent ductus arteriosus (pda).Patient was a 24-week gestation premature infant.The implant procedure was successful.The device was implanted in the intraductal position, and there was no evidence of left pulmonary artery (lpa) stenosis.On routine one year follow up, a mild increase in lpa velocity was noted on echocardiography.Subsequent follow up showed further increase in lpa velocity suggestive of lpa stenosis.In (b)(6) 2024, the patient was referred for a lung perfusion scan, which showed 80% flow to the right pulmonary artery (rpa) and 20% flow to the lpa.The decision was made to take to the catheter lab for angiographic assessment of the lpa blood flow.On (b)(6) 2024, a balloon angioplasty was performed on the lpa, which was successful in relieving the lpa stenosis and improving blood flow to the left lung.The peak lpa gradient decreased from 18mmhg to 9mmhg, confirming a satisfactory result.It was reported that the device likely tilted/migrated from the intraductal position to an extraductal position with the proximal disk of the device situated in the pulmonary artery at the bifurcation of the left branch pulmonary artery.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received and per event details, the cause of reported event could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as a balloon angioplasty was performed on the lpa to relieving the lpa stenosis and improving blood flow to the left lung.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2021, a 4mm by 2mm amplatzer piccolo occluder was implanted in a 3 week old, 800g patient to close a patent ductus arteriosus (pda).Patient was a 24-week gestation premature infant.The implant procedure was successful.The device was implanted in the intraductal position, and there was no evidence of left pulmonary artery (lpa) stenosis.On routine one year follow up, a mild increase in lpa velocity was noted on echocardiography.Subsequent follow up showed further increase in lpa velocity suggestive of lpa stenosis.In (b)(6) 2024, the patient was referred for a lung perfusion scan, which showed 80% flow to the right pulmonary artery (rpa) and 20% flow to the lpa.The decision was made to take to the catheter lab for angiographic assessment of the lpa blood flow.On (b)(6) 2024, a balloon angioplasty was performed on the lpa, which was successful in relieving the lpa stenosis and improving blood flow to the left lung.The peak lpa gradient decreased from 18mmhg to 9mmhg, confirming a satisfactory result.It was reported that the device likely tilted/migrated from the intraductal position to an extraductal position with the proximal disk of the device situated in the pulmonary artery at the bifurcation of the left branch pulmonary artery.The patient status was reported as stable.

• Brand Name: AMPLATZER PICCOLO
• 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: 20644750
• Report Number: 2135147-2024-05639
• Device Sequence Number: 20683712
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)250531(10)7547226
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 7547226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2020
• 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: 21 DA
• Patient Sex: Male
• Patient Weight: 1 KG