MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR AND BILIARY STENT SYSTEM

Catalog Number	VIUS10040
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Vascular System (Circulation), Impaired (2572)
Date of Event	10/06/2016
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 further patient or procedural details to date.
Event or Problem Description
It was reported that the stent was deployed in the iliac vein and allegedly moved to an unintended location in the vena cava resulting in the deployment of an additional stent to bridge both stents.Reportedly, the stent was intended to be placed in the iliac vein in a leg graft.The stent remains implanted and 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.No sample was returned.On the basis of the evaluation of the images provided, the reported malposition of the stent could be confirmed.As reported, the stent had been deployed in the iliac vein and then migrated to the vena cava.The stent deployment process and the reported stent migration could not be verified on the basis of the images; however, the images show the stent being positioned in the vena cava.Based on the images, no defect or deficiency of the stent could be identified.The fully expanded stent shows a regular stent strut structure.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported application represents an off-label use of the device which is considered a significant contributing factor to the reported stent migration.An unintended movement of the delivery system during stent deployment also may lead to stent migration.Also a too fast stent deployment may cause an insufficient wall apposition and subsequent stent migration.On the basis of the information available and the evaluation of the images, a definite root cause for the reported event could not be determined.The ifu states: "visually inspect the bard lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment." also the ifu states: "prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement." and "as with all self-expanding nitinol stents, careful attention during stent deployment is warranted to mitigate the potential for movement of the stent." furthermore, the ifu states: "to maximize stent placement accuracy, slowly and deliberately deploy the distal portion of the stent until you have visual confirmation of wall apposition before steadily deploying the remaining length of the stent." and "appropriate diameter sizing of the stent to the target lesion is required to reduce the possibility of stent migration." additionally, the ifu indicates that the bard lifestar vascular stent system is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length with a reference vessel diameter of 5 to 9 mm.
Event or Problem Description
It was reported that the stent was deployed in the iliac vein and allegedly moved to an unintended location in the vena cava resulting in the deployment of an additional stent to bridge both stents.Reportedly, the stent was intended to be placed in the iliac vein in a leg graft.The stent remains implanted and there was no reported patient injury.

• Brand Name: LIFESTAR VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6050148
• Report Number: 9681442-2016-00272
• Device Sequence Number: 77882
• Product Code: FGE
• UDI-Device Identifier: 04049519005546
• UDI-Public: (01)04049519005546(17)180616(10)ANZF1489
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• 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): 10/07/2016

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: 06/16/2018
• Device Catalogue Number: VIUS10040
• Device Lot Number: ANZF1489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 12/22/2016
• 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
• Patient Age: 45 YR