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

Catalog Number EX061703C

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/08/2022

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.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 sample was not available for evaluation.Provided x-ray images/ movies demonstrate the placed stent inside the vessel; the stent is fractured and the stented section is occluded.The stent appeared irregular; a stent length measurement was not possible, a more detailed description was not possible.Based on the information available the investigation is confirmed for stent fracture, and vessel occlusion.A definite root cause for the reported event 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 state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit.' holding and handling of the system throughout deployment was found closely 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.' in regards to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques', 'post stent expansion with a pta catheter is recommended.' (expiry date: 05/2023).

Event Description

It was reported that approximately two months post stent placement in the left superficial femoral artery via right femoral access, the stent allegedly ruptured with a filling defect.Reportedly, the patient came to the hospital for re examination and atherectomy was performed for thrombus removal, and an additional stent was placed for treatment.The current status of the patient is 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.Investigation summary: the sample was not available for evaluation.Provided x-ray images/ movies demonstrate the placed stent inside the vessel; the stent is fractured and the stented section is occluded.The stent appeared irregular; a stent length measurement was not possible, a more detailed description was not possible.An indication for a process related issue could not be found.Based on the information available the investigation is confirmed for stent fracture and vessel occlusion.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 stent system.Remove the stent system as possible and replace with a new unit.' holding and handling of the system throughout deployment was found closely 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.' in regards to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques', 'post stent expansion with a pta catheter is recommended.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 Description

It was reported that approximately two months post stent placement via left superficial femoral artery, the stent allegedly ruptured.It was further reported that the stent was removed.The procedure was completed using an another device.Reportedly, the patient came to the hospital for additional intervention and medication was allegedly prescribed for pain.The current status of the patient is unknown.

• 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: 14332440
• MDR Text Key: 291487532
• Report Number: 9681442-2022-00146
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001500
• UDI-Public: (01)04049519001500
• 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,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061703C
• Device Lot Number: ANFS2103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG