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

Catalog Number	EX071503CS
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528); Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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 system would not release the stent fully.The device was removed with a partial of the stent and the other part deployed in the sfa.Doctor would like both stents replaced.There was no reported patient injury.
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.
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 sample was found with activated deployment mechanism, and with a separately included fractured stent.The length of the returned stent end, and the condition of the sample indicate, that the stent was approximately 105mm partially deployed when the issue occurred.Inside grip the metal guide tube was found heavily kinked, and a force transmitting post was found broken.A guidewire was found stuck inside the system.The investigation leads to confirmed result for kink of the guiding tube leading to release force increase, and break of a force transmitting post inside grip, and subsequent partial deployment leading to stent fracture upon removal.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/ deployment, and during deployment the system was being gently held at the stability sheath and kept stationary.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter kink, break inside grip, partial stent deployment, stent fracture, and difficult removal caused by stuck guidewire.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use (ifu) state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.', and 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' holding and handling of the system throughout deployment was found described.The ifu further 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.' and 'predilation of the lesion should be performed using standard techniques.' and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' d2b (nip; fge), g3, h6 (device, component, 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.
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 system would not release the stent fully.The device was removed with a partial of the stent and the other part deployed in the sfa.Doctor would like both stents replaced.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: 22083144
• Report Number: 9681442-2025-00165
• Device Sequence Number: 15425050
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326(17)270116(10)ANKN1544
• 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): 06/26/2025

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: EX071503CS
• Device Lot Number: ANKN1544
• 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