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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	01/10/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 4 mm x 2 mm amplatzer piccolo occluder was chosen for implantation utilizing a 4f amplatzer torqvue delivery system.The patient was a premature infant (dob (b)(6) 2024) with a hemodynamically significant patent ductus arteriosus (pda).Patient was referred for transcatheter closure following three (3) prior failed attempts to close the pda with medical therapy.The patient weighed 1050 grams at 4 weeks of life.An angiogram demonstrated a pda with a minimal diameter of 2.5 mm, aortic end diameter of 3.3 mm and a length of 11.9 mm.The 04mm x 02mm ampaltzer piccolo occluder was deployed intra-ductal via right femoral venous access without difficulty.Implanting team utilized the piccolo pulse checklist.However, following device release there was evidence of protrusion into the left pulmonary artery (lpa) causing partial obstruction and a decision was made to attempt retrieval of the device with a 5 mm gooseneck snare and subsequent repositioning.However, during the attempt to retrieve the device the device was inadvertent dislodged into the main pulmonary artery and additional attempts were made to retrieve the device with a 5 mm gooseneck snare.In the process of attempting to retrieve the device with a snare, the piccolo occluder embolized further into the right pulmonary artery (rpa) and additional attempts were made to retrieve the occluder using a combination of a 4 french cook flexor sheath (45 cm) and an inner 4 french terumo glide catheter.However, the device could not be retrieved, and the patient began to develop bradycardia and had hemodynamic instability.The patient was taken to surgery where the device was explanted and the pda ligated surgically.The patient's chest was left open post surgery.The patient post-operatively initially was improving but subsequently worsened and a decision was made to withdraw support on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that following piccolo device release there was evidence of protrusion into the left pulmonary artery (lpa) causing partial obstruction.An unsuccessful attempt was made to retrieval of the device; however, the device inadvertently dislodged into the main pulmonary artery and additional attempts were made to retrieve the device.The piccolo occluder embolized further into the right pulmonary artery (rpa).After additional unsuccessful attempts of device retrieval the patient began to develop bradycardia and had hemodynamic instability.The patient was taken to surgery where the device was explanted and pda ligated.Post-operatively the patient initially improved, but subsequently deteriorated and a decision was made to withdraw support and the infant expired on the sixth post-operative day.A returned device assessment could not be performed as the device was not returned for analysis.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, the recommended size device was used.Information from field indicated that the piccolo device was deployed intra-ductal via right femoral venous access without difficulty.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 medical review performed at abbott, due to the prolonged attempts to retrieve the device along with the surgery to explant the device, the patient most likely had complications from surgery that ultimately led to the post-operative clinical decline and fatality.Based on the information received, the cause of the reported device migration could not be conclusively determined.The reported patient effects bradycardia and hypotension appears to be a cascading effect from prolonged attempts to retrieve the device.The cause of reported patient death is possibly related to the complication from surgery.The reported medical and surgical intervention were result of case-specific circumstances as embolized device was attempted to be snared and was surgically removed.There were no complaints associated with any other devices from the lot.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: 21309418
• Report Number: 2135147-2025-00544
• Device Sequence Number: 8243799
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)290831(10)10513416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/28/2025

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 Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 10513416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: 4F AMPLATZER TORQVUE DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Death
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 1 KG