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

Model Number 9-PDAP-05-02-L

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Embolism (1829)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 5-4 amplatzer piccolo was selected for implant for a (b)(6) day old (b)(6) kg patient.The pda dimension was: 2.9mm minimal diameter, 4.4mm aortic ampulla, and 9.22m pda length.The 5-4 piccolo was deployed but not released as it was determined to not fit the pda appropriately.The device was removed and exchanged for a 5-2 piccolo and placed intraductal.Upon release, the 5-2 piccolo shifted toward the pulmonary artery.The device was snared in the inferior vena cava and migrated to the right pulmonary artery.The device was snared in the right pulmonary artery and removed.The physician reattempt to place the 5-2 piccolo in the pda.The placement looked good and it was decided to release the device.Ten minutes post release, the device embolized and was again snared and removed from the patient without incidence.An echo was performed and showed that was no valvular regurgitation or damage to the tricuspid valve or pulmonary valve.A large pda remained and the baby was referred to the surgery team for ligation.The baby remained very stable throughout the entire case.

Manufacturer Narrative

An event of migration was reported.A more comprehensive assessment could not be performed as a valve-in-valve procedure was performed and the device was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.A capa has been initiated to further investigate the reported event.Please note per the instruction for use, arten600042307 version a, a pda in a patient weighing fewer than 2kg and a pda with a minimum diameter of 2.9 mm and a length of 9.22mm, a 4/2mm piccolo is recommended per the sizing table.

Event Description

On (b)(6) 2020, a 5-4 amplatzer piccolo was selected for implant for a 31 day old 1.9kg patient.The patent ductus arteriosus (pda) dimension was: 2.9mm minimal diameter, 4.4mm aortic ampulla, and 9.22m pda length.The 5-4 piccolo was deployed but not released as it was determined to not fit the pda appropriately.The device was removed and exchanged for a 5-2 piccolo and placed intraductal.Upon release, the 5-2 piccolo shifted toward the pulmonary artery.The device was snared in the inferior vena cava and migrated to the right pulmonary artery.The device was snared in the right pulmonary artery and removed.The physician reattempt to place the same 5-2 piccolo in the pda again.The placement looked good and it was decided to release the device.Ten minutes post release, the device embolized and was again snared and removed from the patient without incidence.An echocardiography was performed and showed that that was no valvular regurgitation or damage to the tricuspid valve or pulmonary valve.A large pda remained and the baby was referred to the surgery team for ligation.The baby remained very stable throughout the entire case.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10596894
• MDR Text Key: 213684268
• Report Number: 2135147-2020-00417
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7162176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 DA
• Patient Weight: 2