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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/10/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 4mm x 2mm amplatzer piccolo occluder (8133391) was selected for implant using a 4f amplatzer torqvue low profile catheter to close a patent ductus arteriosus (pda).During procedure, the device was not able to be released from the delivery system.The device was then removed from the patient, and another 4mm x 2mm amplatzer piccolo occluder (8002426) was successfully implanted.There were no signs of obstruction of the aorta upon echo evaluation and doppler measurement.Overnight, the device was discovered to have shifted and was causing severe obstruction of the descending aorta.The device was removed surgically on (b)(6)2022.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of device migration, causing obstruction of the aorta so the device was explanted was reported.Also reported was that the patient developed necrotizing enterocolitis was a surgical complication from the removal of the device, and the patient died due to the necrotizing enterocolitis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A review of the measurements provided from the field indicated that the correct device size per the instructions for use (a 4/2mm piccolo) was chosen for implant.Information from the field indicated that the migration was suspected to be caused by patent ductus arteriosus constriction following the implant of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient had patent ductus arteriosus (pda) dimensions of minimal diameter 2.8 mm, length of 7 mm, and diameter at aortic ampulla of 3.3 mm.The 4mm x 2mm amplatzer piccolo occluder (8002426) was placed extraductal on the aortic side.Following procedure, the device was discovered to have shifted.The cause of the migration was suspected to be due to pda constriction following the release of the device.The migration of the device caused a severe obstruction of the descending aorta.The device was emergently removed surgically on (b)(6) 2022.After the device was explanted, the pda was closed with surgical ligation.During recovery from this event, the patient developed necrotizing enterocolitis (nec) as a post-surgical complication, which was a direct result of hypoperfusion to the lower body from the device malposition.The patient died on (b)(6) 2022.No additional information was provided.

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14636295
• Report Number: 2135147-2022-00352
• Device Sequence Number: 12032812
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 8002426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP CATHETER, 9-TVLPC4F90/080
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 30 DA
• Patient Sex: Male
• Patient Weight: 980 KG