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)

Patient Problem Embolism (1829)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 2135147-2020-00444.On (b)(6) 2020, a 5/2 amplatzer piccolo occluder was selected for implant in a (b)(6) old, (b)(6) kg patient with patent ductus arteriosus dimensions of: minimal diameter 3.1mm, length of 4.6mm and diameter at aortic ampulla of 6.5mm.During the procedure the device was placed intraductal and as soon as the device was released from the cable the device embolized into the left pulmonary artery(lpa).The device was retrieved using a transcatheter snare without complication and a 5/4 amplatzer piccolo occluder was selected for implant.The 5/4 amplatzer piccolo occluder was placed in the patient and looked to be in good position and the procedure was completed.Within a couple of hours the 5/4 amplatzer piccolo occluder embolized into the patient's lpa.The patient was brought back into the cath lab and the device was retrieved using a transcatheter snare and a 6/4 amplatzer duct occluder was implanted.The patient did not experience any serious injuries and is currently stable and discharged.

Manufacturer Narrative

The report was submitted under the incorrect product code.The correct product code is mae.Corrected information for: d2.Additional information for: d10, g4, g7, h2, h3, h6, and h10.An event of embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A capa was initiated for further investigation on device embolization, per internal procedures.Please note per the instruction for use, arten600042307 version b, that for a pda with a minimum diameter of 3.1mm and a length of 4.6mm a 5/4mm piccolo is recommended per the sizing table.

• 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: 10718775
• MDR Text Key: 212514006
• Report Number: 2135147-2020-00443
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7432692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5-4 AMPLATZER PICCOLO; 5-4 AMPLATZER PICCOLO
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6