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

Catalog Number	EX071503CS
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H11: d2b (nip; fge).H11: section a through f ¿ the information provided 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 xl vascular stent.During the procedure, the stent failed to cross the lesion due to extreme calcification.Upon trying to cross the lesion the deployment catheter broke.The stent and deployment system were able to be removed with nothing left behind.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: 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 catheter sample is in locked condition with loaded stent.The secondary sheath is broken in the mid section, and during evaluation testing, a system compatible 0.035" guidewire could not be inserted because it got stuck inside the lumen.The investigation leads to confirmed result for failure to advance, and break of the secondary sheath.A manufacturing related issue could not be found.In this case the vessel was extremely calcified but not tortuous, the lesion was pre dilated, and the guidewire was running smoothly inside the system.6fx45cm introducer with 0.018" guidewire were used for access.Based on the investigation of the provided information, the investigation is closed as confirmed for failure to advance and catheter break.A definite root cause for the reported event could not be determined.Labelling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use (ifu) state: 'if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.' regarding pta the ifu state: 'predilation of the lesion should be performed using standard techniques.' regarding accessories the ifu state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.B) insert a 0.035¿ diameter guidewire(.) it is recommended to use the 80 cm working length device for ipsilateral procedures.' b5, d2b (nip; fge), g3, h6 (component, method, result, conclusion) section a through f ¿ the information provided 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 xl vascular stent in sfa for stenosis via ipsilateral access site.During the procedure, the stent failed to cross the lesion due to extreme calcification.Upon trying to cross the lesion the deployment catheter broke.The stent and deployment system were able to be removed with nothing left behind.There was no reported patient injury.

• Brand Name: LIFESTENT XL 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: 22083150
• Report Number: 9681442-2025-00164
• Device Sequence Number: 7885170
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326(17)260905(10)ANJW0574
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/20/2025

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: 09/05/2026
• Device Catalogue Number: EX071503CS
• Device Lot Number: ANJW0574
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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 Sex: Unknown