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

Catalog Number	EX071703CS
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Torqued (2980); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any patient or further procedural details to date.
Event or Problem Description
It was reported that during a stent placement procedure, the user experienced difficulties in the middle of deployment.On the image taken post deployment, the vascular stent was found to be completely twisted in the middle section.In order to open the twisted vascular stent, a stent graft was placed inside the stent immediately.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.An image and the sample were returned.The provided image was documenting the expanded stent in a vessel.An hour glass like deformation in the mid section of the stent confirmed that the stent was twisted.Based on the condition of the returned delivery system a deployment difficulty could not be confirmed.The delivery system was found in used condition and during evaluation testing the system was found fully functioning without conspicuity.No indication could be found for a process related issue.Previous investigations of similar complaints have been reviewed.A root cause analysis for the failure mode of twisted stents has been previously performed to determine the root cause for this kind of event.Based on the root cause analysis performed, twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Due to the helical structure the stent has an inherent tendency to rotate upon deployment of the delivery system.The failure mode may occur when this rotational movement is constricted during stent deployment or when rotational forces are applied externally on the stent.There may be also various physical forces, including individual patient factors, contributing to the twisting of a stent in this region.Not performed balloon pre-dilation may be a contributing factor.On the basis of the available information and the performed evaluation, a definite root cause could not be identified.The ifu states: ¿to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment (.).Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position (.).While maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1 cm minimum (.).With distal end of the stent apposing vessel wall, deployment continues with the following method: while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end¿.In regards to pta, the ifu states: ¿predilation of the lesion should be performed using standard techniques¿ and ¿post stent expansion with a pta catheter is recommended¿.Updated ¿device code + description¿, ¿device code + description2¿ and ¿eval code & desc - conclusion1¿.
Event or Problem Description
It was reported that during a stent placement procedure, the user experienced difficulties in the middle of deployment.On the image taken post deployment, the vascular stent was found to be completely twisted in the middle section.In order to open the twisted vascular stent, a stent graft was placed inside the stent immediately.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6099068
• Report Number: 9681442-2016-00291
• Device Sequence Number: 18903926
• Product Code: NIP
• UDI-Device Identifier: 04049519001005
• UDI-Public: (01)04049519001005(17)170630(10)ANZF3712
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EX071703CS
• Device Lot Number: ANZF3712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention