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

Model Number EX072003CL

Device Problems Fracture (1260); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problems Claudication (2550); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer; however a photo was provided and a photo review will be performed.As the lot number for the device was not provided, a manufacturing review could not be performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event is currently underway the information provided by bard 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 bard.

Event Description

It was reported that approximately three months post stent placement in the popliteal artery, the stent allegedly had multiple fractures.It was further reported, the patient returned with reoccurring symptoms (claudication) which may have required medical intervention.Current patient status is unknown.

Manufacturer Narrative

Manufacturing review: the lot number was not reported.A review of lot records could not be performed.It was therefore not known whether the reported issue was a potential manufacturing related issue.Investigation summary: based on the images provided it was confirmed that two stents had been placed with overlapping technique and that the stent in distal position was found twisted and fractured.A detailed description of the fracture was not possible due to poor image quality.Potential factors that could have led or contributed to the reported event have been evaluated.Based on the images provided, the evaluation was closed as confirmed for stent twisting.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 address 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.' (b)(4).

Event Description

It was reported that approximately three months post overlapping stent placement in the popliteal/ femoral artery, the stent in distal position allegedly had multiple fractures.It was further reported, the patient returned with reoccurring symptoms (claudication) which may have required medical intervention.Current patient status is unknown.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7249160
• MDR Text Key: 99303957
• Report Number: 9681442-2018-00011
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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 Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR