MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number	5F070803CS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent stent placement procedure using lifestent.Allegedly during the procedure, the inner catheter tip broke off after successful stent deployment.The delivery tip was successfully snared and retrieved.
Event or Problem Description
On (b)(6) 2025, a patient underwent stent placement procedure using lifestent.During the procedure, the inner catheter tip allegedly broke off after successful stent deployment.The delivery tip was successfully snared and retrieved.
Additional Manufacturer Narrative
H11: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product, and the product was found to have met the specification prior to shipment.Investigation summary: the returned sample is in used condition with activated deployment mechanism, and without stent that reportedly has been deployed inside patient.The inner catheter cardan tube is broken at the distal end, and the distal end of the cardan tube including tip, and both 1/4 rings is separately included.The used snare device is part of the sample return.The investigation leads to confirmed result for break and detachment of the inner catheter cardan tube inside patient.An indication for a manufacturing related cause could not be found.In this case 6fx45cm introducer with 0.035" guidewire were used for access, the vessel was not tortuous/calcified, and the lesion was pre-dilated.The guidewire was running smoothly inside the system, and the user did not experience difficulty during deployment nor during insertion/ removal.The product was used off label in the iliac artery.Based on the information available, the investigation is closed with confirmed result for break and detachment of the inner catheter cardan tube inside patient.A definite root cause for the reported event could not be determined.The reported indication represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use (ifu) states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pre dilation the ifu states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the ifu further state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of appropriate length and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter (.)'.Regarding insertion and removal difficulty of the delivery system the ifu states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.The lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenostic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and popliteal artery.E1, g3, h6 (method, result, conclusion).Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22987227
• Report Number: 9681442-2025-00294
• Device Sequence Number: 9549462
• Product Code: NIP
• UDI-Device Identifier: 00801741120336
• UDI-Public: (01)00801741120336(17)270712(10)ANJU2118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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 Catalogue Number: 5F070803CS
• Device Lot Number: ANJU2118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/06/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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