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

Catalog Number EX072003JL

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem Stenosis (2263)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record 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.The catalog number identified has not been cleared in the us but is similar to the lifestent solo vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent system products are identified.(expiry date: 04/2020).Device not returned.

Event Description

It was reported that about ten months after the stent placement procedure, the stent of the device allegedly found to be twisted and severe stenosis in the stent area.The procedure was completed using another device.Current status of patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 device was not returned for evaluation.Two photos of an x-ray screen were provided for evaluation.A twisted section of the stent placed in the sfa could be confirmed, which could have caused the reported occlusion of the stent.Based on the root cause analysis performed, twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Due to the helical structure the stent has an inherent tendency to rotate upon deployment of the delivery system.The failure mode may occur when this rotational movement is constricted during stent deployment or when rotational forces are applied externally on the stent.Incorrect holding of the delivery system during stent release, insufficient pre and/or post dilatation, highly calcified vessel, patient condition or the vessel anatomy may be contributing factors.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.Based on the instructions for use stent fracture, migration, and occlusion, as well as malposition may occur during use of this type of device.More specific the instructions for use states that cases of stent fracture occurred in lesions that were 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.Correct deployment of the stent was found to be properly described.E.G., 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 as necessary." the instructions for use further states: "confirm that the introducer sheath is secure and will not move (¿) gently hold the stability sheath at or proximal to the orange marking and maintain it straight and under tension throughout the procedure.(¿) initiate stent deployment by pushing the micro-trigger.(¿) continue pushing the trigger until the distal end of the stent obtains complete wall apposition." h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent system products are identified in d2 and g4.H10: d4 (expiry date: 04/2020), g3.H11: h6 (method, result and conclusion).H11: section a through f ¿ the information provide 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.

Event Description

It was reported that about ten months after the stent placement procedure, the placed stent was found to be twisted with a severe stenosis in the stent area.The procedure was completed using another device.Current status of patient is unknown.

• Brand Name: LIFESTENT SOLO STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10958041
• MDR Text Key: 219995200
• Report Number: 9681442-2020-20064
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX072003JL
• Device Lot Number: ANCR1794
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention