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

Model Number	EX071503CS
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, an image was provided for review.The investigation of the reported event is currently underway.(expiration date: 02/2024).Device not returned.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly fractured upon deployment.There was no reported patient injury.
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: the catheter sample is not available for evaluation.Provided image demonstrates a mid-section of the stent.Deformation is visible but due to poor resolution a more detailed strut evaluation is not possible.A stent fracture or twist could not be confirmed.The vessel was tortuous/ calcified, the lesion was pre dilated, and the user did not experience difficulty during deployment.The system was correctly held at the stability sheath, and torque was neither felt nor exerted.Based on the investigation of the provided information, the investigation is closed as confirmed for stent deformation.A definite root cause for the reported event could not be determined.Placement in the iliac artery represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿ diameter guidewire (.)', and 'predilation of the lesion should be performed using standard techniques.' holding and handling of the system was found sufficiently described, in particular the instruction for use state: 'remove slack from the stent system held outside the patient.', and 'to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.' the lifestent xl vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.H10: b5, d4 (expiration date: 02/2024), g3, h6 (device) h11: h6 (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 distal left common iliac via radial access, the stent was allegedly fractured shortly after deployment.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 16492838
• Report Number: 9681442-2023-00067
• Device Sequence Number: 6374543
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Model Number: EX071503CS
• Device Catalogue Number: EX071503CS
• Device Lot Number: ANGP2836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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