MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT; VENOUS STENT

Catalog Number	EX062003CL
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: based on the event description the severity of this issue was classified as marginal health hazard.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 locked condition and the stent is loaded without tip to sheath gap.During evaluation testing a system compatible 0.035" guidewire gets stuck underneath the kink protection when inserted from both ends; a break is present on the outer layer of the black proximal sheath underneath the kink protection (without separation) which leads to blockage of the guidewire which leads to confirmed result for catheter break and failure to advance over guidewire.A manufacturing related issue could not be found.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The ifu state: 'advance the stent system over the 0.035¿ guidewire through the sheath introducer.', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' 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 a stent placement procedure using the lifestent solo stent.During the procedure, the stent allegedly failed to advance into the sheath by the sheath loading onto the wire.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT
• Common Device Name: VENOUS 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: 22606092
• Report Number: 9681442-2025-00218
• Device Sequence Number: 9565135
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303(17)260105(10)ANJN0701
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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 Expiration Date: 01/05/2026
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANJN0701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 82 KG