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

Model Number	9-PDAP-04-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 4x4mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer tvlp catheter in a patent ductus arteriosus (pda) occlusion procedure.The dimensions of the defect were measured as 4.1 mm at the aorta, 2.7 mm at the pulmonary end, and 7.5 mm in length.The sizing of the device was determined using angiography and transesophageal echocardiography.During the procedure, angiography and transesophageal echocardiography were utilized as imaging modalities.At the time of release, the team encountered difficulty, noting that the device appeared to be tightly attached to the screw, which resulted in the device twisting along its axis.Consequently, its position was altered within the heart, leading to embolization after release.The migration/embolization was identified through angiography.The device completely dislodged from the implant site.The implanter believes the cause of embolization was difficulty releasing the prosthesis, with twisting of the prosthesis within its own shaft.A stability check was performed, and no leak was detected around the lobe of the device during the procedure.The patient did not experience any rhythm change or clinical signs or symptoms during or after the event.There was no difficulty with implanting the device, such as multiple recaptures or repositioning.Following embolization, a percutaneous recapture attempt with a snare was performed; however, retrieval was unsuccessful as the device lodged distally in a small branch of the right pulmonary artery, causing a partial obstruction of blood flow.The retrieval was not considered an emergency procedure to prevent permanent impairment or death.The procedure was completed using a new 4x4 mm amplatzer piccolo occluder.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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) 2025, a 4x4mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer tvlp catheter in a patent ductus arteriosus (pda) occlusion procedure.The dimensions of the defect were measured as 4.1 mm at the aorta, 2.7 mm at the pulmonary end, and 7.5 mm in length.The sizing of the device was determined using angiography and transesophageal echocardiography.During the procedure, angiography and transesophageal echocardiography were utilized as imaging modalities.At the time of release, the team encountered difficulty, noting that the device appeared to be tightly attached to the screw, which resulted in the device twisting along its axis.Consequently, its position was altered within the heart, leading to embolization after release.The migration/embolization was identified through angiography.The device completely dislodged from the implant site.The implanter believes the cause of embolization was difficulty releasing the prosthesis, with twisting of the prosthesis within its own shaft.A stability check was performed, and no leak was detected around the lobe of the device during the procedure.The patient did not experience any rhythm change or clinical signs or symptoms during or after the event.There was no difficulty with implanting the device, such as multiple recaptures or repositioning.Following embolization, a percutaneous recapture attempt with a snare was performed; however, retrieval was unsuccessful as the device lodged distally in a small branch of the right pulmonary artery, causing a partial obstruction of blood flow.The retrieval was not considered an emergency procedure to prevent permanent impairment or death.The procedure was completed using a new 4x4 mm amplatzer piccolo occluder.
Additional Manufacturer Narrative
The investigation for (b)(6) is determined to be a duplicate of (b)(6).Please refer to (b)(6) for the investigation.

• 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: 24098825
• Report Number: 2135147-2026-00338
• Device Sequence Number: 21397325
• Product Code: MAE
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 10430737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown