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

Catalog Number EX072001JL

Device Problem Material Twisted/Bent (2981)

Patient Problem Injury (2348)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return.The investigation is currently underway.The catalog number identified has not been cleared in the u.S.But, it is similar to the lifestent solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified.

Event Description

It was reported that the stent was allegedly found twisted in the right superficial femoral artery two weeks after implantation; as a result, the healthcare provider allegedly performed an additional procedure to implant a new stent inside of the twisted stent, preventing future occlusion.

Manufacturer Narrative

H10: manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: based on the images provided it was confirmed that two stents had been placed with overlapping technique as the stent in distal position was found twisted.A manufacturing related issue was not identified.The twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Based on the information available, a definite root cause could not be identified.Labeling review: in reviewing the applicable labeling for this product, it was found that the instructions for use sufficiently addresses the potential risk of a stent twisting and subsequent fracture.The ifu closely describes the stent deployment procedure.The ifu states: 'confirm that the introducer sheath is secure and will not move during deployment (.)the second hand should be used to support the stent delivery system.Gently hold the stability sheath at or proximal to the orange marking and maintain it straight and under tension throughout the procedure (.) do not constrict the delivery system during stent deployment (.) initiate stent deployment by pushing the trigger.Six micro-triggers result in one full trigger.While using fluoroscopy, maintain position of the distal and proximal stent radiopaque markers relative to the targeted site.Continue pushing the trigger until the distal end of the stent obtains complete wall apposition.With the distal end of the stent apposing the vessel wall, final deployment can be continued with full triggers.Deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall.Pre- and post-dilation was found to be addressed: 'predilation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.' h11: b5, h6(results, 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 the stent was allegedly found twisted in the right superficial femoral artery two weeks after implantation via right inguinal; as a result, the healthcare provider allegedly performed an additional procedure to implant a new stent inside of the twisted stent, preventing future occlusion.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8693787
• MDR Text Key: 147855318
• Report Number: 9681442-2019-00075
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112041
• UDI-Public: (01)00801741112041
• 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: 07/31/2019

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: EX072001JL
• Device Lot Number: ANCW1194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 57