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

Model Number EX062003CL

Device Problems Fracture (1260); Difficult to Remove (1528); Misfire (2532)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Images were provided to the manufacturer and are being reviewed.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 during a peripheral leg case to treat the femoral artery via a contralateral approach, the vascular stent allegedly fractured and a segment remained in the patient.Therefore, another manufacturer's stent was used to press the segment against the vessel wall.It was further reported that upon removal, the guidewire became allegedly stuck with the catheter.So, the guidewire and the catheter were removed as one unit.However, access was not lost as the introducer sheath remained in place.Reportedly, the procedure was completed, and the patient is doing well.

Event Description

It was reported that during a peripheral leg case to treat the femoral artery via a contralateral approach, the vascular stent allegedly fractured and a segment remained in the patient.Therefore, another manufacturer's stent was used to press the segment against the vessel wall.It was further reported that upon removal, the guidewire became allegedly stuck with the catheter.So, the guidewire and the catheter were removed as one unit.However, access was not lost as the introducer sheath remained in place.Reportedly, the procedure was completed, and the patient is doing well.

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: based on the investigation of the returned catheter sample and the provided images it was confirmed that the user actively used the deployment system and that the system could only partially deploy the stent which resulted in stent fractured upon removal.Furthermore, the guidewire was found stuck inside the system, as alleged.A force transmitting component was found fractured at the distal end which confirmed high release force, and which made a complete deployment of the stent impossible.Excessive release force during stent deployment was considered as reason for partial stent deployment and subsequent stent fracture upon removal.Difficult patient anatomy or challenging placement site may lead to friction increase and deployment failure.In this case the tracking vessel was reported as tortuous, and calcification was visible on the images provided.The lesion was pre dilated and difficulty advancing to the lesion site was not experienced.The stuck guidewire was considered a consequence of high deployment force leading to lumen deformation (catheter pig tail like deformed) and subsequent patency reduction.Based on the information available, and the evaluation of the returned catheter sample, 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 (ifu) sufficiently address the potential risks.The ifu states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' the ifu further states: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' and 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.'.

• 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: 7351327
• MDR Text Key: 102865023
• Report Number: 9681442-2018-00038
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANBR1701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 73