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); Migration (4003)

Patient Problems Embolism (1829); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)

Event Date 06/21/2020

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 5-2 amplatzer piccolo was selected for implant for a 7 weeks old, 1500 grams patient.The patient has the following patent ductus arteriosus (pda) dimension: minimal diameter: 3.5mm and length: 8.0mm.The device was implanted extraductal.On (b)(6) 2020, the device embolized, obstructing the aorta.The device was surgically removed and the pda was surgically closed.There were no other complications reported.

Manufacturer Narrative

Additional information for: g4, g7, h2, h6, and h10.An event of an amplatzer 5-2 piccolo occluder embolizing 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 a, the correct size piccolo occluder for the measurements provided was a 9-pdap-05-02-l, which is consistent with the implanted 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.A capa was initiated for further investigation on the device embolization, per internal procedures.

Manufacturer Narrative

Corrected information section: d2.

Event Description

After discussion between an abbott medical director and the surgeon regarding this event, the following information was obtained: on (b)(6) 2020, a 5/2 amplatzer piccolo occluder was selected for implant in a 7 week old, 1.665kg infant with a large patent ductus arteriosus(pda).The pda measurements were: minimal diameter of 3.5mm, length of 8mm.The device was implanted intraductal in the patient and the post-deployment echo showed good position of the device.However, imaging the next day showed migration of the device into the aorta.The device was displaced so that the aortic disc was totally within the lumen of the aorta and there was a weak pulse below the device.The patient was taken to surgery and underwent successful removal of the piccolo occluder, pda ligation and repair of the aortic incision.There were no other complications reported.

Manufacturer Narrative

Additional information that was reported in manufacturing report number: 2135147-2021-00024 is now being reported in here.An event of "device displaced so that the aortic disc was totally within the lumen of the aorta" and "a weak pulse was noted below the 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 a, the correct size piccolo occluder for the measurements provided was a 9-pdap-05-02-l, which is consistent with the implanted 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.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: 10299358
• MDR Text Key: 199661701
• Report Number: 2135147-2020-00327
• 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,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 6860141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 WK
• Patient Weight: 1