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

Catalog Number	EX062001CL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during a stent placement procedure for treatment of an occlusion in the sfa, the vascular stent could not be deployed while using a 0.014" guide wire.After the usage of a 0.035" guide wire, there was not any deployment issue and the stent could be deployed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
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 all specifications prior to shipment.On the basis of the evaluation of the returned sample it was confirmed that the system was actively used and that the stent could not be deployed at all.A force transmitting joint was found broken in the distal section of the delivery system which made a stent deployment impossible.Potential factors that could have led or contributed to the deployment failure have been evaluated.Previous investigations of similar complaints have been reviewed.Reportedly, more force was needed as usual for system activation and during evaluation a necking pattern was found in the distal catheter section.Both situations indicating a high release force.Therefore, the event may be related to a difficult anatomy as highly tortuous and calcified vessels may lead to increased friction and subsequent release force increase.Reportedly, the anatomy was calcified; a pre-dilation was performed.Furthermore, the event reported may be use related as rough handling may lead to deformation and subsequent friction increase.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.The ifu states: "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." and "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".
Event or Problem Description
It was reported that during a stent placement procedure for treatment of an occlusion in the sfa, the vascular stent could not be deployed while using a 0.014" guide wire.After the usage of a 0.035" guide wire, there was not any deployment issue and the stent could be deployed successfully.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5782190
• Report Number: 9681442-2016-00191
• Device Sequence Number: 599456
• Product Code: NIP
• UDI-Device Identifier: 04049519004105
• UDI-Public: (01)04049519004105(17)161030(10)ANYJ3354
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: EX062001CL
• Device Lot Number: ANYJ3354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 08/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 73