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

Catalog Number	EX061703CS
Medical Device Problem Codes	Break (1069); Fracture (1260); Misfire (2532); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a stent placement procedure, the stent had allegedly flowered and stopped deployment.It was further reported that the distal portion of the stent and the delivery system was allegedly broken in the introducer sheath.Reportedly, the broken pieces of the nose cone and stent was allegedly stuck on the wire.Furthermore, the patient's superficial femoral artery damage was allegedly due to dragging partially deployed stent out.The current status of the patient is unknown.
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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: 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.
Additional Manufacturer Narrative
H10: 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 with partially deployed stent.The stent is fractured off twice at the distal end, and the segments are separately included.The distal end of the guidewire lumen including tip was broken off and separately included.During testing, the remainder of the loaded stent could be manually deployed at high force level but primary sheath and secondary sheath were found stuck against each other.The force transmitting cassette post was found broken inside grip.The investigation leads to confirmed result for partial deployment, break of a force transmitting post, break and detachment of the inner catheter guidewire lumen at the distal end, and stent fracture.The vessel was not tortuous/ calcified, the lesion was pre dilated, and 0.018" guidewire with 6f introducer were used for access.Stent fracture and break of the inner catheter guidewire lumen were considered consequences of the removal attempt of the partially deployed/ anchored stent.Based on the investigation of the provided information, the investigation is closed as confirmed for break, partial deployment, and stent fracture.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 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.' the instructions for use 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 (.)', and 'predilation of the lesion should be performed using standard techniques.' packaging pictograms indicate the use of a 0.035" guidewire.Holding and handling of the system during deployment was found sufficiently described, in particular the instructions for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' h10: g3, h6 (component).H11: h6 (method, result, conclusion).H11: 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
It was reported during a stent placement procedure, the stent had allegedly flowered and stopped deployment.It was further reported that the distal portion of the stent and the delivery system was allegedly broken in the introducer sheath.Reportedly, the broken pieces of the nose cone and stent was allegedly stuck on the wire.Furthermore, the patient's superficial femoral artery damage was allegedly due to dragging partially deployed stent out.The current status of the patient is unknown.

• 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: 21694656
• Report Number: 9681442-2025-00094
• Device Sequence Number: 9059110
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961(17)260423(10)ANJR3229
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2026
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANJR3229
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Black Or African American