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

Catalog Number 9-PDAP-05-04-L

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Dyspnea (1816); Obstruction/Occlusion (2422)

Event Date 11/10/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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 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
• 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: 17652155
• MDR Text Key: 322306643
• Report Number: 2135147-2023-03769
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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; Hospitalization
• Patient Age: 25 DA
• Patient Sex: Male