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

Catalog Number	5F070803CS
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: 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 sample is not available.One of two provided x-ray images demonstrates a poorly self expanded stent inside the vessel with varying diameter which leads to confirmed result for poor self expansion.A second x-ray image demonstrates the same vessel section with expanded stent.Contrast changes of the stented section may indicate changes in strut coverage and may indicate elongation/ foreshortening; but it is not clearly visible how many stents have been placed which also may have an impact on the contrast of the stented section.The resolution of both images is very poor, and calcification seem to be present so that single struts are not visible; a more detailed evaluation is not possible.Adequate scaling information is not part of the image so that a length measurement is not possible.The investigation leads to confirmed result for poor self expansion of the first stent placed, and inconclusive result for the second stent placed; stent shortening cannot be confirmed because of missing adequate scaling information and poor resolution.Potential product and non-product related factors which may have caused or contributed to the reported failure were considered.Therefore, previous investigations of similar complaints were reviewed.Stent shortening during deployment may occur when the relative movement between inner catheter including pusher and outer stent sheath is inverted during deployment; meaning that the outer stent sheath is stationary and the inner catheter including pusher is moving forward because of increased friction on the distal outer moving parts (note during regular deployment the inner catheter is stationary and the stent sheath moves in grip direction).Poor self expansion of the stent may be related to oversizing of the stent, insufficient pre expansion, or irregular deployment such as foreshortening/ elongation.Therefore, the reported issue may be related to incorrect holding or handling during deployment, difficult vessel anatomy/ challenging placement site, or accessories used.Deployment without pta may be a contributing factor to friction increase or poor self expansion.In this case only limited information was provided.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.Holding and handling of the system throughout deployment was found described.In particular the instructions for use state: 'prior to and during stent deployment, remove slack from the delivery system catheter outside the patient by gently holding the stability sheath and keeping it straight and under tension.' regarding access/ accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing an 5f (1.67 mm) or larger introducer sheath.Insert a guidewire of appropriate length (table 3) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter(.).' the instructions for use further state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' a stent size selection table is part of the instructions for use describing the relationship between vessel diameter and stent diameter.Section a through f - the information provided by bd represents all of 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
A patient underwent a stent placement procedure using two lifestent devices.Allegedly 7x100 mm lifestent did not expand to its full intended length and there were also deployment challenges with the second stent 7x80 mm lifestent.There was no reported patient injury.

• 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: 23519752
• Report Number: 9681442-2025-00365
• Device Sequence Number: 9613209
• Product Code: NIP
• UDI-Device Identifier: 00801741120336
• UDI-Public: (01)00801741120336(17)280325(10)ANKQ2919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/31/2025

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: ANKQ2919
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/11/2025
• 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