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

Catalog Number EX051503C

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

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.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.Device not returned.

Event Description

It was reported that during a stent placement procedure via left superficial femoral artery, the stent was allegedly broken.It was further reported the vessel was blocked.Reportedly, the patient was transferred to the hospital for thrombus aspiration.There was no reported patient injury.

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: 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 was not returned for evaluation.One x-ray image was provided demonstrating a short mid-section of the stent inside the vessel.The resolution is poor so that a strut fracture cannot be identified.A strut disorder is visible, but a closer description is not possible due to poor resolution which leads to confirmed result for stent strut deformation.A 6f introducer with 0.018" guidewire were used for access, no difficulty was experienced during deployment, the vessel was not tortuous but calcified, and the lesion was pre and post dilated; strut irregularity was not observed directly after stent placement.A manufacturing related issue could not be found.Based on the information available the investigation is closed with confirmed result for stent strut deformation.A definitive root cause could not be determined based upon the available information.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 states: "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 states: "predilation of the lesion should be performed using standard techniques", "post stent expansion with a pta catheter is recommended." the instructions for use further state: "cases of fracture have been reported in clinical use of the lifestent vascular stent.Cases of stent fracture occurred 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." in regard to guidewire size the instructions for use states: "insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length (.)" h10: d4 (expiry date: 07/2023).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.H3 other text : device not returned.

Event Description

It was reported that to a post stent placement procedure via left superficial femoral artery, the stent was allegedly broken.It was further reported the vessel was blocked.Reportedly, the patient was transferred to the hospital for thrombus aspiration.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: 15637486
• MDR Text Key: 304787712
• Report Number: 9681442-2022-00308
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007779
• UDI-Public: (01)04049519007779
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX051503C
• Device Lot Number: ANFU1179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 60 KG