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

Catalog Number EX061703C

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 04/03/2023

Event Type  Injury  

Event Description

It was reported that one month and nineteen days post stent placement in superficial femoral and popliteal artery via left common femoral artery access, an arteriographic examination revealed that the stent allegedly fractured in the median area of the femoral stent.It was further reported that another arteriographic examination revealed that the stent was allegedly found with thrombosis and fractured in the middle third.It was also reported that thrombectomy and angioplasty were performed for fracture of the stent mesh resulted in a complete fracture of the stent, allowing the passage of material to finish the thrombectomy.Furthermore, a large number of thrombi, and intrastent stenosis were observed after thrombectomy.Reportedly, further angioplasty was performed and coated stents were positioned performing endo bridge covering areas of thrombi and stent fracture.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: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, images and videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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.H3 other text : device not returned.

Event Description

It was reported that one month and nineteen days post stent placement in superficial femoral and popliteal artery via left common femoral artery access, an arteriographic examination revealed that the stent allegedly fractured in the median area of the femoral stent.It was further reported that another arteriographic examination revealed that the stent was allegedly found with thrombosis and fractured in the middle third.It was also reported that thrombectomy and angioplasty were performed for fracture of the stent mesh resulted in a complete fracture of the stent, allowing the passage of material to finish the thrombectomy.Furthermore, a large number of thrombi, and intrastent stenosis were observed after thrombectomy.Reportedly, further angioplasty was performed and coated stents were positioned performing endo bridge covering areas of thrombi and stent fracture.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.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 device was not returned for evaluation.Provided x-ray images and video files confirm a twisted section of the stent placed in the superficial femoral artery.The stent was placed overlapping with another stent, and the twisted section was found just below the overlapping zone.The alleged stent fracture could not be verified.Therefore, based on the information available, it is confirmed that the stent placed in the femoral artery got twisted.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Proper method for stent deployed was found to be addressed; in particular the instructions for use states: "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".Regarding preparation the instructions for use states: "predilation of the lesion should be performed using standard techniques" and "gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035inch (0.89 mm) diameter guidewire of appropriate length".H10: d4 (expiration date: 03/2024), g3 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.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: 16901282
• MDR Text Key: 314887537
• Report Number: 9681442-2023-00177
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001500
• UDI-Public: (01)04049519001500
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: EX061703C
• Device Lot Number: ANGQ0569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/01/2023
• 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: 80 YR