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

Model Number EX062003CL

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.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 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 one stent was found to be fractured 24 months post placement, in the distal 1/3 of sfa for treatment of a 100% stenosis.Additional tvr (target vessel revascularisation) was performed.Patient status is unknown.

Event Description

It was reported that one stent was found to be fractured 24 months post placement, in the distal 1/3 of sfa for treatment of a 100% stenosis.Additional tvr (target vessel revascularisation) was performed on the external iliac and common femoral arteries.Patient status is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot history records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.Investigation summary: based on the images provided a stent fracture could not be confirmed.The images documented a severely calcified vessel and a placed stent, however, a strut fracture could not be identified.Therefore, the investigation will be closed with inconclusive result.A manufacturing related issue could not be determined.Potential factors that could have led or contributed to the event reported have been evaluated.Based on the information available and the evaluation of the images provided, a definite root cause for the event reported could not be identified.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu addresses 'stent fracture' as a potential adverse event that may occur.The ifu states: 'cases of fracture have been reported in clinical use of the lifestent solo vascular stent.Cases of stent fracture occurred in lesions that were moderate to severely 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.' the stent deployment procedure was found properly described; the ifu states: '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.' and 'pull back the stent system until the distal and proximal stent radiopaque markers are in position so that they are distal and proximal to the target site.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.' the ifu further states: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.'.

• 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: 7249047
• MDR Text Key: 99274375
• Report Number: 9681442-2018-00009
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

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 Expiration Date: 10/30/2016
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANYJ3358
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN; HEPARIN; LOVENOX; LOVENOX; XARELTO; XARELTO; HEPARIN; LOVENOX; XARELTO
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 102