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

Catalog Number EX051703C

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

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

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were 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 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.Medical device - expiry date: 01/2023.Device not returned.

Event Description

It was reported that approximately one month post stent placement procedure in the femoral artery, the stent allegedly found to be twisted, tangled and ruptured upon re-radiography examination.It was further reported that open surgery was required for further surgical treatment.The current status of the patient is unknown.

Event Description

It was reported that approximately one month post stent placement procedure in the femoral artery, the stent allegedly found to be twisted, tangled and ruptured upon re-radiography examination.It was further reported that open surgery was required for further surgical 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: 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 sample was not returned for evaluation.Ct images were provided demonstrating the vessel condition with contrasted blood; deformation of the vessel is visible, however, the stent strut structure is not visible on the images so that a statement about twisting, fracture, tangling cannot be made.The alleged issue cannot be re produced which leads to inconclusive evaluation result.Pre and post dilation were performed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, potential factors for the reported issue were found addressed.The instructions for use closely describes holding and handling of the system throughout deployment; in particular the instructions for use states: "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.".In regards to pta the instructions for use state: "predilation of the lesion should be performed using standard techniques" and "post stent expansion with a pta catheter is recommended." h10: d4 (expiry date: 01/2023), g3.H11: 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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13087640
• MDR Text Key: 282775485
• Report Number: 9681442-2021-00644
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007786
• UDI-Public: (01)04049519007786
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX051703C
• Device Lot Number: ANFN2635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• 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