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

Catalog Number EX061503C

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/30/2021

Event Type  Injury  

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.The catalog number identified has not been cleared in the us but is similar to the lifestent stent products that are cleared in the us.The pro code and 510k number for the lifestent stent products is identified.(expiry date: 08/2022).

Event Description

It was reported that after stent placement, the stent allegedly found to be fractured.Additional medical intervention was performed.The current patient status 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 510k number for the lifestent xl vascular stent products is identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 physical sample is not available.One provided image demonstrates the placed stent in the femoral popliteal artery with poor resolution.The lesion was pre dilated but the product was used for in-stent restenosis in the p2/p3 segment.In the stented section a segment is poorly visible without stent struts; it was assessed to be likely that this segment represents a stent fracture with axial displacement.The investigation is therefore confirmed for stent fracture.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.Holding and handling of the system throughout deployment was found sufficiently described; in particular the instructions for use state: the instructions for use further state: '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.' regarding pta the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.' the instructions for use further state: 'the lifestent xl vascular stent is intended for primary stenting of de-novo or restenotic lesions of the peripheral arteries.' and 'the safety and effectiveness of stent overlapping in the middle (p2) and distal popliteal artery (p3) has not yet been established.', and 'the safety and effectiveness of this device for use in treatment of instent restenosis has not been established.' h10: d4 (expiry date: 08/2022), g3.H11: d1, h6 (method, result, conclusion).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 after stent placement, the stent allegedly found to be fractured.Additional medical intervention was performed.The current patient status was unknown.

• Brand Name: LIFESTENT XL
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11883061
• MDR Text Key: 252665816
• Report Number: 9681442-2021-00334
• Device Sequence Number: 1
• Product Code: NIP
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061503C
• Device Lot Number: ANEV2847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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 Sex: Male
• Patient Weight: 60 KG