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

Catalog Number	9-PDAP-05-02-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm x 2mm amplatzer piccolo occluder was chosen for implant in a patent ductus arteriosus (pda), using 04f amplatzer torqvue low profile catheter.The physician measured the ductus as length 14.99 mm, aortic ampulla 5.33 mm, mid duct tightest spot 4.09 mm, the left pulmonary artery (lpa) opening was 3.44 mm.During placement attempts of the device, it was noted to be sitting a bit proximal.It was agreed that the device is ok to be released.During the release, the device stretched a bit anteriorly and then immediately after release compacted and shifted anteriorly.In the implanter¿s opinion, the cause of migration was due to device size and movement on release.As the position of the device was unsatisfactory, it was decided to remove the device via snare.The snaring process went well initially; however, there was an error with the snare, where the pressure was released from the snare and the device fell off the snare into the inferior vena cava (ivc).The device was recaptured and removed from the patient.A replacement 5mm x 4mm amplatzer piccolo occluder was used to complete the procedure.The patient is reported to be doing well and recovering.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device and 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.Based on the information received, the root cause of the reported incident could not be conclusively determined.However, it was reported that the cause of migration was due to device size and movement on release.
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm x 2mm amplatzer piccolo occluder was chosen for implant in a 30-week old, 950g patient with a patent ductus arteriosus (pda), using 04f amplatzer torqvue low profile catheter.The physician measured the ductus as length 14.99 mm, aortic ampulla 5.33 mm, mid duct tightest spot 4.09 mm, the left pulmonary artery (lpa) opening was 3.44 mm.During placement attempts of the device, it was noted to be sitting a bit proximal.It was agreed that the device is ok to be released.During the release, the device stretched a bit anteriorly and then immediately after release compacted and shifted anteriorly.In the implanter¿s opinion, the cause of migration was due to device size and movement on release.As the position of the device was unsatisfactory, it was decided to remove the device via snare.The snaring process went well initially; however, there was an error with the snare, where the pressure was released from the snare and the device fell off the snare into the inferior vena cava (ivc).The device was recaptured and removed from the patient.A replacement 5mm x 4mm amplatzer piccolo occluder was used to complete the procedure.The patient is reported to be doing well and recovering.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.

• 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: 17612362
• Report Number: 2135147-2023-03709
• Device Sequence Number: 18020211
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/26/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 8452383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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 LOW PROFILE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 1 KG