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

Catalog Number	VIUS10060
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that one end of the stent did not self-expand after deployment and therefore, a balloon was needed to open the stent completely.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 evaluation of the returned device, the reported stent expansion issue could not be confirmed.The stent delivery system was returned in deployed configuration and no conspicuity could be found indicating an improper stent expansion.No images were provided for evaluation.Potential contributing factors to the reported event have been evaluated.As the reported event is considered an isolated incident, no previously reported similar complaint could have been reviewed.The reported event may be related to strut interaction during deployment, a difficult vessel anatomy or a formation of resistant vessel wall material.In this case, the lesion had been pre-dilated.As reported, a pta resistant restenosis was reported.The target site was not tortuous or calcified and the stent could be released without difficulty.The reported application represents an off-label use of the device which may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be identified.The ifu states: "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." and "post-dilatation of the stent with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." also 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." the ifu states that the lifestar vascular stent system is indicated for the treatment of illiac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries.
Event or Problem Description
It was reported that one end of the stent did not self-expand after deployment in the brachial vein for treatment of a stenosis in an a/v fistula.A balloon catheter was used to expand the stent completely.There was no reported patient injury.

• Brand Name: LIFESTAR VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6422228
• Report Number: 9681442-2017-00117
• Device Sequence Number: 853004
• Product Code: FGE
• UDI-Device Identifier: 04049519005553
• UDI-Public: (01)04049519005553(17)191110(10)ANAY1289
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 11/10/2019
• Device Catalogue Number: VIUS10060
• Device Lot Number: ANAY1289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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: 64 YR
• Patient Weight: 111