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

Model Number	VIUS10060
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
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 stenting procedure for treatment of a pre-dilated upper axillary a/v graft stenosis, it was difficult to deploy the stent.During the attempt to retract the y adapter resistance was experienced; however, the stent could be deployed successfully at the target site without further issues.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 deployment difficulties could not be confirmed.The deployment system was found to have been fully activated upon sample receipt and the stent was found to be released.No deformation leading to or resulting from a difficult deployment could be identified.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.As reported, resistance was felt during deployment.This kind of event may be associated with a difficult vessel anatomy or a challenging stent placement site leading to high friction during the attempt to release the stent.As reported, the lesion had been pre-dilated.The device was used for treatment of an a/v graft stenosis in the axiliary artery 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 determined.The ifu states: "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." and "do not hold the delivery system catheter during stent deployment." the reported application represents an off-label use of the device.As per ifu, the product is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries.
Event or Problem Description
It was reported that during a stenting procedure for treatment of a pre-dilated upper axillary a/v graft stenosis, it was difficult to deploy the stent.During the attempt to retract the y adapter resistance was experienced; however, the stent could be deployed successfully at the target site without further issues.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: 6522362
• Report Number: 9681442-2017-00155
• Device Sequence Number: 13455484
• Product Code: FGE
• UDI-Device Identifier: 04049519005553
• UDI-Public: (01)04049519005553(17)191216(10)ANAZ2273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/17/2017

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: 12/16/2019
• Device Model Number: VIUS10060
• Device Catalogue Number: VIUS10060
• Device Lot Number: ANAZ2273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 04/01/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 73