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

Catalog Number	EX071503CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	06/18/2024
Type of Reportable Event	Serious 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 device has not been returned to the manufacturer for evaluation.However, a image was provided for review.The investigation of the reported event is currently underway.H10: d2b (fge), d4 (expiration date: 01/2026).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
H10: manufacturing review: a manufacturing related root cause was considered; therefore, the lot history records 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 stent or the delivery system were not available for evaluation.Provided x-ray image demonstrates an hourglass like deformation of the stent inside vessel which confirms stent twisting.In this case 6f introducer with 0.014" guidewire were used for access, the vessel was not tortuous but calcified, and the lesion was pre and post dilated.During deployment, the user did not encounter difficulty, torque was neither felt nor exerted, and an irregular stent strut structure was not seen.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.A definite root cause for the reported event could not be determined.Labeling/packaging review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The ifu closely describes holding and handling of the system during deployment; in particular the ifu state: 'confirm that the introducer sheath is secure and will not move during deployment.(¿) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.(¿) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.' in regarding pta, the ifu state: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' h10: d4 (expiration date: 01/2026), h11: d2b (nip; fge), h6(patient, method, result, conclusion) 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
It was reported that during a stent placement procedure in the calcified left superficial femoral artery via the right common femoral artery, the stent was allegedly twisted.It was further reported that the patient allegedly experienced occlusion.Reportedly, the patient was transferred to a vascular surgeon to treat the reoccluded superficial femoral artery.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a stent placement procedure in the calcified left superficial femoral artery via the right common femoral artery, the stent was allegedly twisted.It was further reported that the patient allegedly experienced occlusion.Reportedly, the patient was transferred to a vascular surgeon to treat the reoccluded superficial femoral artery.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: 19771123
• Report Number: 9681442-2024-00187
• Device Sequence Number: 8777923
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Catalogue Number: EX071503CS
• Device Lot Number: ANHX1475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG