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

Catalog Number EX062003JL

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2018

Event Type  Injury  

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 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 deployment via a contralateral approach in the right sfa the vascular stent allegedly partially deployed, fractured, and a segment remained in the patient.It was further reported that the delivery system was removed without incident, and the fracture segment was dilated with a pta balloon securing it against the vessel wall.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was 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 that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned catheter it was confirmed that the deployment mechanism could only partially deploy the stent and that the partially deployed stent fractured upon removal.A force transmitting joint was found broken which made a complete deployment impossible.Further use of the failed deployment system led to further damage and subsequent delivery system separation.Increased friction during deployment was considered as reason for increased release force and subsequent joint failure/partial stent deployment.Based on the available information and the evaluation of the returned sample the investigation was confirmed.A definite root cause for the reported event could not be determined.The placement of the stent inside another stent represents an off label use of the device.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 'during stent deployment, passing with adjunct devices must be performed with caution'.The device is intended for the treatment of symptomatic arterial de-novo or recurrent stenotic or occluded lesions up to 200 mm in length in native superficial femoral artery and proximal popliteal artery.In regards to overtriggering the ifu states: 'do not push the trigger after the stent is fully deployed', however, in this case the delivery system failed so that the stent could not be fully deployed.

Event Description

It was reported that during deployment via a contralateral approach in the right sfa the vascular stent allegedly partially deployed.Reportedly, as the vascular stent was attempted to deploy through an additional access behind the knee, the stent allegedly fractured and a segment remained in the patient.It was further reported that the delivery system was removed without incident, and the fractured segment was dilated with a pta balloon securing it against the vessel wall.There was no reported patient injury.

Event Description

It was reported that during an overlapping deployment procedure via a contralateral approach in the right sfa the vascular stent allegedly partially deployed.Reportedly, as the vascular stent was attempted to deploy through an additional access behind the knee, the stent allegedly fractured and a segment remained in the patient.It was further reported that the delivery system was removed without incident, and the fractured segment was dilated with a pta balloon securing it against the vessel wall.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was 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 that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the deployment mechanism could only partially deploy the stent and that the partially deployed stent fractured upon removal.A force transmitting joint was found broken which made a complete deployment impossible.Further use of the failed deployment system led to further damage and subsequent delivery system separation.Increased friction during deployment was considered as reason for increased release force and subsequent joint failure/ partial stent deployment.Based on the available information and the evaluation of the returned sample the investigation was confirmed.A definite root cause for the reported event could not be determined.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 'during stent deployment, passing with adjunct devices must be performed with caution'.In regards to overtriggering the ifu states: 'do not push the trigger after the stent is fully deployed', however, in this case the delivery system failed so that the stent could not be fully deployed.

• 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: 7343845
• MDR Text Key: 102574763
• Report Number: 9681442-2018-00035
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112058
• UDI-Public: (01)00801741112058
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2018

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 Expiration Date: 11/30/2019
• Device Catalogue Number: EX062003JL
• Device Lot Number: ANBY2084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 05/03/2018
• Supplement Dates FDA Received: 04/26/2018; 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 72