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

Model Number 9-PDAP-04-02-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914)

Event Date 12/04/2020

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 4/2 amplatzer piccolo occluder was selected for implant in (b)(6) day old (b)(6) kg patient with the following patent ductus arteriosus(pda) dimensions of: minimal diameter of 2.6mm, length of 10mm and diameter at aortic ampulla of 4mm.During the procedure the device was deployed intraductal, but when the device was released from the delivery cable it embolized into the left pulmonary artery.Multiple attempts were made to retrieve the device and the device was ultimately removed from the patient using a snare.The patient became hypotensive during the retrieval attempts and was stabilized using medication.A 5/2 amplatzer piccolo occluder was then selected and placed intraductal in the patient.There was a 2 hour clinically significant delay in the procedure.The patient is currently stable.

Manufacturer Narrative

An event of embolization of the 4/2mm 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, arten600042307 version b, the correct size piccolo occluder for the measurements provided was the 4/2mm piccolo.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.A capa was initiated for further investigation on the device embolization per internal procedures.

• 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: 11099017
• MDR Text Key: 224858679
• Report Number: 2135147-2020-00558
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 7572179
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 DA
• Patient Weight: 1