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

Model Number	9-PDAP-04-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021, a 3/4 amplatzer piccolo occluder was selected for implant in a (b)(6) day old (b)(6) kg patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 2.1mm, pda length of 9mm and diameter at aortic ampulla of 3.7mm.During the procedure the device was placed intraductal, but was mis-sized too small.The device was removed and exchanged for a 4/4 amplatzer piccolo occluder.The replacement device was placed in an acceptable position with the same initial delivery system (ds), but upon releasing the device, the occluder shifted into a different position in the pda.As there were concerns of device embolization, the decision was made to remove the device with a 10mm non-abbott gooseneck snare.The device was successfully removed and a 4/2 amplatzer piccolo occluder was then attempted and successfully implanted to resolve the event.The procedure was not extended longer than is clinically significant and the patient remained hemodynamically stable throughout.The patient is stable with no adverse consequences.
Additional Manufacturer Narrative
An event of device embolism was reported.The investigation confirmed the device met visual and dimensional specifications when analyzed at abbott.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600059267 rev.B, the correct size piccolo occluder for the measurements provided was 4/2mm, consistent with the successfully 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 incident could not be conclusively determined.A capa was initiated for further investigation into complaints regarding embolization and migration of piccolo occluder per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12202384
• Report Number: 2135147-2021-00293
• Device Sequence Number: 14509887
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7211201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 DA
• Patient Weight: 2