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

Catalog Number UNK LIFESTENT VASCSTNT SYS

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  malfunction  

Event Description

It was reported that approximately one month post stent placement procedure in the femoral artery, the stent allegedly fractured.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.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 one month post stent placement procedure in the femoral artery, the stent allegedly fractured.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as the lot number for the device was not provided.Investigation summary: the physical device was not returned for evaluation.Provided images demonstrate overlappingly placed stents in the sfa and complete transversal fracture directly distal to the overlapping zone; further distal the stent has a multiple strut fracture.The investigation leads to confirmed result for strut fracture.Therefore, based on the investigation of the provided information, the investigation is closed as confirmed for the reported strut fracture issue.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 closely describes holding and handling of the system for regular deployment, in particular the instructions for use states: 'confirm that the introducer sheath is secure and will not move during deployment firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath.Do not constrict the stent delivery sheath during stent deployment'.In regard to 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'.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 was found mentioned as a potential adverse event that may occur; the instructions for use further states: 'cases of fracture have been reported 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'.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.

• Brand Name: LIFESTENT 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: 17142568
• MDR Text Key: 317319783
• Report Number: 9681442-2023-00233
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIFESTENT VASCSTNT SYS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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