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

Catalog Number EX061503CS

Device Problem Material Deformation (2976)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

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: no device sample and no x-ray images were provided.Therefore, the alleged stent foreshortening could not be verified, and the investigation is closed with inconclusive result.The procedure was performed crossover, but no difficult anatomy was reported.There was no reported increased deployment force and there were no issues to track the device to the target lesion.A guidewire with a smaller diameter than recommended was used by the customer.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the alleged issue could not be determined.Labeling review: relevant labeling in particular the instructions for use for the vascular indication of this device was reviewed.Regarding preparation and accessories, the instructions for use states: "position the tip of the stent system past the target site.Pull back the stent system until the distal and proximal ends of the stent are in position so that they are distal and proximal to the target site.Remove slack from the stent system held outside the patient." in addition, the instructions for use states: "gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿diameter guidewire of appropriate length across the lesion to be stented via the introducer sheath.Predilation of the lesion should be performed using standard techniques.Regarding proper stent deployment the instructions for use states: "to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Note: do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment." h10: d4 (expiration date: 10/2025).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 during a stent placement procedure in the superficial femoral artery via the left femoral artery crossover approach, the stent allegedly foreshortened to hundred millimeters or shorter.The procedure was completed by using another device.There was no reported patient injury.

• 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: 18738564
• MDR Text Key: 336859017
• Report Number: 9681442-2024-00020
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANHX2282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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 Sex: Male
• Patient Race: White