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

Catalog Number	EX062001CL
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2016
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 the vascular stent was deployed properly at the target site, however, the delivery system could not be retracted over the guide wire.Therefore, the outer catheter was cut at the handle, the introducer sheath was pulled off the wire, and then the outer catheter was removed together with the guide wire.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.There is no indication for a manufacturing-related failure.On the basis of the condition of the returned stent delivery system, the reported event could be confirmed.The stent was found to be completely deployed.It was not returned as it remains implanted.The sheath of the delivery system was found to be separated from the handle as it had been cut off by the user.The trigger mechanism of the delivery system was found to have been continuously activated (overtriggered) although the stent had been already fully released.This led to high compressive load and subsequent deformation of the outer sheath resulting in the reported removal difficulties and crimping of the outer sheath distal to the handle.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.Although the user reported that the trigger activation was discontinued after stent deployment, the returned device indicated that the trigger mechanism had been continuously activated after the complete release of the stent.Rough handling of the device as well as a difficult vessel anatomy may be contributing factors to increased friction between guide wire and guide lumen.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together.".

• 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: 5627151
• Report Number: 9681442-2016-00125
• Device Sequence Number: 16278405
• Product Code: NIP
• UDI-Device Identifier: 04049519004105
• UDI-Public: (01)04049519004105(17)161030(10)ANYJ3354
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P070014/S048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2016

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: 05/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 07/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 87