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

Model Number 9-PDAP-05-04-L

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

Patient Problem Embolism (1829)

Event Date 01/10/2020

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 (lot # 6974979) was selected for implant for a (b)(6) month old (b)(6) kg patient with the following type a patent ductus arteriosus (pda) dimensions: 2.5mm minimal diameter, 5.8mm at the aortic end, and 7.2mm length.The device was placed and after multiple attempts, was determined mis-sized too small.The device was removed and exchanged for a 4-4 amplatzer piccolo (lot # 6800257), which was determined to be mis-sized too small as well.The 4-4 piccolo was removed and exchanged for a 5-4 piccolo (lot #7005306), which was placed across the pda.After an angiogram, it was decided the device closure was sufficient and showed no obstruction to pulmonary artery flow.The patient was returned to the nicu.On x-ray in the nicu it was found that the 5-4 piccolo device had embolized in the right pulmonary artery.The patient was immediately brought back to the cath lab and the 5-4 piccolo device was successfully removed using a 4 french glide cath and a 10mm gooseneck snare device.A 5-4 ado (lot # 7040697) device was placed and successfully implanted.

Manufacturer Narrative

Additional information: g4, g7, h2, h6 and h10.An event of embolization of the 05-04 piccolo device was reported.A 5/4 amplatzer duct occluder was later implanted.The results of the investigation are inconclusive since 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 a, the correct size piccolo occluder for the measurements provided was 04-06, smaller than the embolized device.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.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

• 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: 9767075
• MDR Text Key: 181827395
• Report Number: 2135147-2020-00077
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• 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: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7005306
• 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): Other; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 4