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

Catalog Number	VIUS12040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2016
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 after insertion of the delivery system but prior to stent deployment in the iliac artery, three radiopaque markers were observed in the distal section of the delivery system under fluoroscopy.It was identified that the distal stent marker spoons which were supposed to be in line with the catheter marker band were located distal to the marker band of the catheter.Reportedly, the safety clip was in place.The device was removed and the procedure was completed with another device.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.The condition of the returned device confirmed the premature deployment of the stent.The safety clip was found to be in place.On the two images provided a premature stent deployment could be identified as the distal stent markers were in distal position to the marker band of the outer catheter.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The stent was found to be partially released with the safety clip still in place.This type of event may be associated with the transportation or storage of the product.Also the event may be related to insufficient flushing of the device or a difficult vessel anatomy which may cause high friction during advancement.Rough handling of the device may be another contributing factor to the reported event as this may lead to device damage.On the basis of the information available, a definite root cause for the reported event could not be identified.The ifu states: "visually inspect the bard lifestar biliary stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment." and "if the safety clip has been removed or becomes inadvertently detached from the grip, do not use the device." furthermore, the ifu states that the delivery system must be flushed.The reported application represents an off-label use of the device.The bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

• Brand Name: LIFESTAR BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5486206
• Report Number: 9681442-2016-00069
• Device Sequence Number: 341246
• Product Code: FGE
• UDI-Device Identifier: 04049519005614
• UDI-Public: (01)04049519005614(17)180918(10)ANZI2513
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2016

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: 09/18/2018
• Device Catalogue Number: VIUS12040
• Device Lot Number: ANZI2513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 06/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90