MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number	5F051503CS
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one year, nine months and sixteen days stent placement procedure, the stent allegedly fractured and patient allegedly experienced restenosis.However, the current status of patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: no device sample and no x-ray images were provided for evaluation.The reported issue could not be reproduced.Based on information available, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Potential complications and adverse events which may occur during of the device was found addressed in the ifu, e.G., restenosis, stent fracture, stent kinking / collapse, stent migration or stent misplacement.In addition, the ifu states: "cases of fracture have been reported in clinical use of the lifestent vascular stent.Cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture." according to the ifu supplied with this product the lifestent 5f vascular stent system is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and popliteal artery.H11: h6 (method).H11: 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
It was reported that approximately one year, nine months and sixteen days stent placement procedure, the stent allegedly fractured and patient allegedly experienced restenosis.However, the current status of patient is unknown.

• Brand Name: LIFESTENT 5F 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: 20721700
• Report Number: 9681442-2024-00397
• Device Sequence Number: 17072522
• Product Code: NIP
• UDI-Device Identifier: 00801741120664
• UDI-Public: (01)00801741120664(17)250325(10)ANGQ3333
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/28/2025

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: 03/25/2025
• Device Catalogue Number: 5F051503CS
• Device Lot Number: ANGQ3333
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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 Sex: Unknown