MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 7/20/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	428781
Medical Device Problem Codes	Malposition of Device (2616); Activation Problem (4042)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A pulsar-18 t3 stent system was selected for treatment of a mildly calcified venous stenosis in an arteriovenous fistula.Pre-dilatation with 2 balloons (4/20 mm, 5/20 mm) was ineffective.The pulsar-18 t3 was then implanted via a 4f sheath, but after one-third deployment, the stent migrated into the dilated venous segment, leaving two-thirds undeployed.
Additional Manufacturer Narrative
Adapted event description: a pulsar-18 t3 stent system was selected for treatment of a mildly calcified venous stenosis in an arteriovenous fistula.Pre-dilatation with 2 balloons (4/20 mm, 5/20 mm) was ineffective.The pulsar-18 t3 was then implanted via a 4f sheath and after about one third of the stent was released "it automatically slipped out directly to the dilation of the vein, leaving 2/3 of deployment system not opened".Additional information after investigation: after additional correspondence with the local staff, it was confirmed that it was not possible to rescue the stent.It was further clarified that the stent jumped out as soon as the deployment was started.The provided image was taken to show that the stent jumped out when about one third of the stent was deployed.Both, subsequent balloon dilation and snaring were not possible or too complex with high risk of venous wall damage.After its withdrawal, the affected device was discarded at the hospital.Investigation results: neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the complaint event.In addition, the four photographs taken from the angiogram were reviewed.Two photographs show the target lesion in the mid cubital vein and the venous aneurysm prior to stent positioning.The two other photographs show the fully released stent inside the venous aneurysm.The stent appears well expanded with no geometric distortions of the stent structure.The delivery system is not visible.Unfortunately, the quality of the photographs is rather poor.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every scaffold system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the scaffold.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Please note that, according to the ifu, pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.G.Residual stenosis and dissection.Lesions judged to prevent proper treatment with the stent system, including proper placement of the stent or complete inflation of an appropriately-sized angioplasty balloon as well as lesions that lie within or adjacent to an aneurysm are contraindicated.The ifu further advises the user to select an appropriate stent size based on the diameter of the artery adjacent to the lesion and the length of the segment to be stented.
Event or Problem Description
A pulsar-18 t3 stent system was selected for treatment of a mildly calcified venous stenosis in an arteriovenous fistula.Pre-dilatation with 2 balloons (4/20 mm, 5/20 mm) was ineffective.The pulsar-18 t3 was then implanted via a 4f sheath, but after one-third deployment, the stent migrated into the dilated venous segment, leaving two-thirds undeployed.

• Brand Name: PULSAR-18 T3 7/20/90
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23508243
• Report Number: 8043892-2025-10275
• Device Sequence Number: 9037828
• Product Code: NIP
• UDI-Device Identifier: 07640130451520
• UDI-Public: (01)07640130451520(17)280621(10)06252929
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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 Model Number: 428781
• Device Lot Number: 06252929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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