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

Catalog Number	9-PDAP-05-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Codes	Dyspnea (1816); Obstruction/Occlusion (2422)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 5mm by 4mm amplatzer piccolo occluder was successfully implanted, using 04f amplatzer torqvue lp delivery system (tvlp) for a 0.98kg patient with the following patent ductus arteriosus (pda) measurements: minimal diameter of 3.3mm, length of 12mm, and diameter at aortic ampulla of 4.3mm.On (b)(6) 2022, echocardiogram showed that the proximal disk migrated out of ductus, flattened against pulmonary artery and blocking the left pulmonary artery (lpa).The patient experienced difficulty breathing, requiring respiratory bipap support.The patient underwent medical intervention; however, the physician was unable to cross into the lpa.On (b)(6) 2022, the patient underwent surgical lpa angioplasty.Only a portion of the proximal disc which was obstructing the lpa opening was excised by the surgeon.The patient was discharged and reported to be stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of migration of proximal disc out of ductus and patient experiencing difficulty breathing 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.A pulmonary artery angiogram showed complete closure of the ductus arteriosus with evidence of the pulmonic disc extending into the lumen of the pulmonary artery.Based on the available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2022, a 5mm by 4mm amplatzer piccolo occluder was successfully implanted intraductal, using 04f amplatzer torqvue lp delivery system (tvlp) for 25 day old, 0.98kg patient with the following patent ductus arteriosus (pda) measurements: minimal diameter of 3.3mm, length of 11.6mm, and diameter at aortic ampulla of 4.3mm.It was noted that after implant, there was a slight left pulmonary artery (lpa) turbulence caused by the proximal disc; however, in the physician¿s opinion, this was of little concern.On (b)(6) 2022, echocardiogram showed that the proximal disk migrated out of ductus, flattened against pulmonary artery and blocking the lpa.The patient experienced difficulty breathing, requiring respiratory bipap support.The patient underwent medical intervention; however, the physician was unable to cross into the lpa.On (b)(6) 2022, the patient underwent surgical lpa angioplasty.Only a portion of the proximal disc which was obstructing the lpa opening was excised by the surgeon.The patient was discharged and reported to be 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: 17652155
• Report Number: 2135147-2023-03769
• Device Sequence Number: 7502735
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/05/2023

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-PDAP-05-04-L
• Device Lot Number: 8410077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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; Hospitalization
• Patient Age: 25 DA
• Patient Sex: Male