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

Model Number (01)04049519007779

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problem Restenosis (4576)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified.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.(expiry date: 08/2023).

Event Description

It was reported that approximately eight months post a stent placement procedure in the left superficial femoral artery, the stent allegedly fractured.It was further reported that the device had obstruction of flow.The procedure was completed using another device.The patient allegedly experienced restenosis.The current status of the patient was unknown.

Event Description

It was reported that approximately eight months post a stent placement procedure in the left superficial femoral artery, the stent allegedly fractured.It was further reported that the device had obstruction of flow.Reportedly, the patient allegedly experienced restenosis.The procedure was completed using another device.The current status of the patient was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.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 physical sample was not provided for evaluation nor photos or images were provided for evaluation which leads to inconclusive evaluation result.Therefore, based on the information available the investigation is closed with inconclusive result for stent fracture and occlusion.A definitive root cause for the reported issue could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use closely describes holding and handling of the system throughout deployment; in particular the instructions for use states: '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.' regarding pta the instructions for use states: 'predilation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.' the instructions for use further states: 'cases of fracture have been reported in clinical use.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.' regarding access and accessories, the instructions for use states: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire'.Stent fracture and restenosis were found mentioned under potential complications and adverse events.H10: (expiry date: 08/2023).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.H3 other text: device not returned.

• Brand Name: LIFESTENT XL VASCULAR STENT
• Type of Device: 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: 15930226
• MDR Text Key: 304957923
• Report Number: 9681442-2022-00351
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007779
• UDI-Public: (01)04049519007779
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: (01)04049519007779
• Device Catalogue Number: EX051503C
• Device Lot Number: ANFV2045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male