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

Catalog Number EX061503C

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

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported that during a stent implantation procedure in superficial femoral artery, the stent allegedly ruptured in vivo after being released.It was further reported that the stent was not removed from patient's body, and a high-pressure balloon was used to dilation then the operation was completed.There was no reported patient injury.

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the lifestent xl vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent system products are identified.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 were provided for review.The investigation of the reported event is currently underway.Expiry date: 09/2023.

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 system products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent system 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 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: the delivery system was not available for evaluation.X ray images provided demonstrates the deployed stent appearing like an hour glass which confirms stent twist.Strut fracture cannot be confirmed because single struts are not visible.The vessel was not tortuous/ calcified, the lesion was pre dilated, and a 0.018" guidewire with 6f sheath was used for access; the system was correctly held at the introducer, torque was not exerted nor felt, and the user did not experience difficulty during deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.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.The instructions for use closely describes holding and handling of the system during deployment; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.(¿) 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.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.' regarding pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' regarding access and accessories, the instructions for use states: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035inch (0.89 mm) diameter guidewire of appropriate length (.)'.H10: d4 (expiry date: 09/2023), 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.

Event Description

It was reported that during a stent implantation procedure in superficial femoral artery, the stent allegedly ruptured in vivo after being released.It was further reported that the stent was not removed from patient's body, and a high-pressure balloon was used to dilation then the operation was completed.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: 16269905
• MDR Text Key: 308447904
• Report Number: 9681442-2023-00010
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001487
• UDI-Public: (01)04049519001487
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061503C
• Device Lot Number: ANFW0345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male