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

Catalog Number EX061203C

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

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that approximately one month post stent placement to treat the arterial occlusion in the lower extremity via contralateral femoral artery access, the stent was allegedly ruptured.The procedure was completed using another device.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 vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: 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, images and videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2024).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 to treat the arterial occlusion in the lower extremity via contralateral femoral artery access, the stent was allegedly ruptured.The procedure was completed using another device.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 vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot# were reviewed with special attention to the manufacturing and inspection of this 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 issues.Investigation summary: the physical sample was not available, but provided images/movies demonstrate the placed stent inside the vessel with an hourglass like deformation which leads to confirmed result for stent twist.The images also demonstrate the additionally placed stent, as reported.A strut fracture could not be identified.The vessel was tortuous but not calcified, 6f introducer and a 0.035" wire were used for access, the lesion was pre but not post dilated, and the user did not experience difficulty during deployment action; the system was correctly held at the stability sheath, and torque was neither felt nor exerted during deployment, stent irregularity was not observed after deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twist.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 describe holding and handling of the system throughout deployment.In particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment, firmly hold the black system stability sheath throughout 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'.In regards to access and accessories the instructions for use state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length'.H10: d4 (expiration date: 05/2024).H11: h6 (method, result, conclusion).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.

• 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: 17674944
• MDR Text Key: 323191488
• Report Number: 9681442-2023-00312
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001463
• UDI-Public: (01)04049519001463
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061203C
• Device Lot Number: ANGS2158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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