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

Catalog Number	EX071503CS
Medical Device Problem Codes	Break (1069); Fracture (1260); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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.D2b (nip; fge).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 65-year-old female patient underwent a stent placement procedure using the lifestent.During the procedure, the thumb wheel and pull grip malfunctioned got partial deployment.Further, the physician noted the stent housing may have shifted.The procedure was completed using another device.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 sample is in used condition and the stent is partially deployed; the stent is fractured at the distal end, and the distal end of the stent is missing.The system is broken/ cut in various positions, and the grip is disassembled.The condition is poor and it is not known which of these breaks/ cuts/ deformations was caused by disassembly of the system such that a closer evaluation is not possible.In this case 0.014" wire with 7fx45cm introducer were used for access; the vessel was not tortuous but calcified, and the lesion was pre dilated.The returned sample is in poor condition with breaks and cuts caused by disassembly.Based on the investigation of the provided information, the investigation is closed as confirmed for stent partial deployment, stent fracture, and various delivery system breaks.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.Holding and handling of the system throughout the procedure was found sufficiently described.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.' regarding access/ accessories the ifu state: 'a) gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.B) insert a 0.035¿ diameter guidewire (.)'.The ifu further state: 'predilation of the lesion should be performed using standard techniques.' d2b (nip; fge), g3, h6 (component, device, 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 65-year-old female patient underwent a stent placement procedure using the lifestent.During the procedure, the thumb wheel and pull grip malfunctioned and caused partial deployment.Further, the physician noted the stent housing may have shifted.The procedure was completed using another device.There were no reported patient injuries.

• 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: 23578825
• Report Number: 9681442-2025-00376
• Device Sequence Number: 13076383
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326(17)261010(10)ANJX1898
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/09/2025

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: ANJX1898
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic