MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Model Number 5F050803CS

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Fracture (1260); Kinked (1339); Difficult to Remove (1528); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 treatment of a heavily calcified popliteal occlusion via a contralateral approach, the stent allegedly would not deploy.It was further reported that the health care provider removed the glidewire and re-flushed the device through the lumen with contrast and saline while inside the patient.A second attempt to deploy the stent was made, but resistance was felt and a pop noise was heard, possible related to an alleged core wire fracture.The delivery system was removed and upon removal the stent and the glidewire allegedly became stuck.Reportedly, the device and the glidewire were removed as one unit.Access was not lost.The delivery system was exchanged for another and the procedure was completed.There was no reported patient injury.

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 it was confirmed that the user could only partially deploy the stent and that the guide wire got stuck after deployment leading to removal difficulty.Inside the grip the catheter including inserted guidewire were found kinked and bent which indicated that excessive release force must have been present.In the distal section of the delivery system a one sided kink pattern was found which indicated tortuous release condition.It was concluded that increased friction was present during deployment leading to lumen deformation, force increase, and subsequent deployment failure.The stuck guidewire was considered a subsequent event caused by guidewire lumen deformation.A wire fracture could not be identified.An indication for a manufacturing related issue could not be identified.Potential factors that could have led or contributed to the event reported have been evaluated.Previously reported similar complaints have been reviewed to find a root cause.Reportedly, a force increase was felt during deployment, and during evaluation force increasing deformation was found on the returned sample.This kind of issue may be related to difficult patient anatomy, or a challenging placement site.In this case the vessel was reported being heavily calcified.A manufacturing related cause was considered, however, 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.Based on the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.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.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' in regards to pta, the ifu states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the ifu further states: 'advance the stent system over the guidewire through the introducer sheath.'.

Event Description

It was reported that during treatment of a heavily calcified popliteal occlusion via a contralateral approach, the stent allegedly would not deploy.It was further reported that the health care provider removed the glidewire and re-flushed the device through the lumen with contrast and saline while inside the patient.A second attempt to deploy the stent was made, but resistance was felt and a pop noise was heard, possibly related to an alleged core wire fracture.The delivery system was removed and upon removal the stent and the glidewire allegedly became stuck.Reportedly, the device and the glidewire were removed as one unit.Access was not lost.The delivery system was exchanged for another and the procedure was completed.There was no reported patient injury.

• Brand Name: LIFESTENT 5F 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: 7328859
• MDR Text Key: 102086185
• Report Number: 9681442-2018-00032
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120633
• UDI-Public: (01)00801741120633
• 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

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 5F050803CS
• Device Catalogue Number: 5F050803CS
• Device Lot Number: ANBW3158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 98 YR
• Patient Weight: 82