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	Obstruction/Occlusion (2422)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
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 5mm x 4mm amplatzer piccolo occluder was chosen for implant in a 36 week old, 2.2 kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter of 3.8mm, length of 13mm, and diameter at aortic ampulla of 4.2mm.The sizing of the device was determined via fluoroscopy and based on the physician's decision from sizing chart.The occluder was implanted using an amplatzer torqvue low profile catheter.At the moment of release from the cable, the device immediately embolized into the left pulmonary artery (lpa).On imaging review, it was observed that there was no compression of the disc on release, and it had the same native and uncompressed appearance similar to what is seen outside of the body while on the cable during preparation.Once embolized, the device was angled across the artery and did not stop the flow of blood.The physician snared the device and removed it from the lpa, but then the device fell off the snare into the inferior vena cava.The device was captured again with a non-abbott snare and removed from the patient.The physician reported that the device chosen was too small for the pda, and in hindsight should not have been released.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient was reported as stable.The decision was made to surgically close the pda on a later date.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from field indicated that the device immediately embolized upon release.Field also indicated that there were no allegation of malfunction against the abbott device or procedure but believed the device used was too small for the duct.Based on the information received, the root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 15785248
• Report Number: 2135147-2022-02043
• Device Sequence Number: 17311934
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/20/2023

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: 03/31/2024
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 6955230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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: Required Intervention
• Patient Age: 36 WK
• Patient Sex: Female
• Patient Weight: 2 KG