MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 7/30/135; STENT, SUPERFICIAL FEMORAL ARTERY,

Model Number	430508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an aneurysm intervention, it was attempted to treat a dissection in the hepatic artery with the pulsar-18 t3, aware of off-label use.The device was placed into the dissected vessel and the stent was released.When pulling out the delivery system, it was noticed on the angiogram screen that only the proximal marker moved.The distal marker remained at its place.Outside it was realized that the system was obviously broken.
Additional Manufacturer Narrative
The returned pulsar-18 t3 was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided still images from the angiogram were reviewed.The still images of the angiogram show the treatment of the vessel injury in the hepatic artery and the distal marker of the affected pulsar-18 t3.However, the still images did not show the tip fracture of the affected device during withdrawal.During the intervention, a high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires were present in the patient, which might have been a contributing factor for the event.As the full angiographic material was not available, it can neither be confirmed nor denied whether interactions between these devices and the affected pulsar-18 t3 occurred.Investigation of the returned product revealed that the outer shaft was fully retracted, while the inner shaft fractured directly proximal to the tip.A visible spiral-shaped cut was detected at the fracture site.The dimensions of the shaft components comply with the specification.The stent has been successfully released in the patient and was not returned.The handle is undamaged and shows no irregularities.The root cause for the tip fracture is most likely related to the manufacturing process of a component produced by a supplier but it could neither be confirmed nor denied whether the interactions between the high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires contributed to the reported event.The supplier of the affected component was informed and acknowledged the complaint.Additional information collected retrospectively during contact with the physician revealed that that the patient shows no symptoms and is in good health conditions.
Event or Problem Description
During an aneurysm intervention, it was attempted to treat a dissection in the hepatic artery with the pulsar-18 t3, aware of off-label use.The device was placed into the dissected vessel and the stent was released.When pulling out the delivery system, it was noticed on the angiogram screen that only the proximal marker moved.The distal marker remained at its place.Outside it was realized that the system was obviously broken.
Additional Manufacturer Narrative
Additional information received on 15-apr-2025 from the physician who initially treated the patient suggests that the broken tip has likely migrated to the gastroduodenal artery.As it is located in a non-critical segment of the vessel, no further intervention is planned at this time.The returned pulsar-18 t3 was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided still images from the angiogram were reviewed.The still images of the angiogram show the treatment of the vessel injury in the hepatic artery and the distal marker of the affected pulsar-18 t3.However, the still images did not show the tip fracture of the affected device during withdrawal.During the intervention, a high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires were present in the patient, which might have been a contributing factor for the event.As the full angiographic material was not available, it can neither be confirmed nor denied whether interactions between these devices and the affected pulsar-18 t3 occurred.Investigation of the returned product revealed that the outer shaft was fully retracted, while the inner shaft fractured directly proximal to the tip.A visible spiral-shaped cut was detected at the fracture site.The dimensions of the shaft components comply with the specification.The stent has been successfully released in the patient and was not returned.The handle is undamaged and shows no irregularities.The root cause for the tip fracture is most likely related to the manufacturing process of a component produced by a supplier but it could neither be confirmed nor denied whether the interactions between the high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires contributed to the reported event.The supplier of the affected component was informed and acknowledged the complaint.Additional information collected retrospectively during contact with the physician revealed that the patient shows no symptoms and is in good health conditions.
Event or Problem Description
During an aneurysm intervention, it was attempted to treat a dissection in the hepatic artery with the pulsar-18 t3, aware of off-label use.The device was placed into the dissected vessel and the stent was released.When pulling out the delivery system, it was noticed on the angiogram screen that only the proximal marker moved.The distal marker remained at its place.Outside it was realized that the system was obviously broken.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.(cfn/fei (b)(4)).The final report was submitted by biotronik ag (cfn 8043892, fei (b)(4)).Additional information received on 15/04/2025 from the physician who initially treated the patient suggests that the broken tip has likely migrated to the gastroduodenal artery.As it is located in a non-critical segment of the vessel, no further intervention is planned at this time.Investigation results: the returned pulsar-18 t3 was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided still images from the angiogram were reviewed.The still images of the angiogram show the treatment of the vessel injury in the hepatic artery and the distal marker of the affected pulsar-18 t3.However, the still images did not show the tip fracture of the affected device during withdrawal.During the intervention, a high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires were present in the patient, which might have been a contributing factor for the event.As the full angiographic material was not available, it can neither be confirmed nor denied whether interactions between these devices and the affected pulsar-18 t3 occurred.Investigation of the returned product revealed that the outer shaft was fully retracted, while the inner shaft fractured directly proximal to the tip.A visible spiral-shaped cut was detected at the fracture site.The dimensions of the shaft components comply with the specification.The stent has been successfully released in the patient and was not returned.The handle is undamaged and shows no irregularities.The root cause for the tip fracture is most likely related to the manufacturing process of a component produced by a supplier but it could neither be confirmed nor denied whether the interactions between the high number of different devices like aortic stents, stent grafts, stents, catheters and guide wires contributed to the reported event.The supplier of the affected component was informed and acknowledged the complaint.Additional information collected retrospectively during contact with the physician revealed that that the patient shows no symptoms and is in good health conditions.Additional information after investigation: the issue triggered a corrective action in which the supplier identified the most probable root cause as an operator error.During removal of excess overmould material, use of a blade caused cuts in the outer surface of the inner shaft which eventually favored the detachment of the tip during the intervention.To prevent recurrence the corresponding work instructions were updated and operators retrained.The effectiveness of the corrective action was verified, and since its implementation, no further complaints with the same root cause have been received.

• Brand Name: PULSAR-18 T3 7/30/135
• 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, OR 8180 ; SZ 8180 ; 8772459800
• MDR Report Key: 21481176
• Report Number: 1028232-2025-01041
• Device Sequence Number: 8436434
• Product Code: NIP
• UDI-Device Identifier: 07640130447066
• UDI-Public: (01)07640130447066(17)270903(10)08242601
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430508
• Device Catalogue Number: 430508
• Device Lot Number: 08242601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 04/28/2025; Not provided
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/07/2025; 04/28/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Patient Sex: Unknown