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

Model Number	VIUS08060
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that the stent allegedly failed to deploy from the delivery system.Reportedly, the delivery system was removed from the patient without incident, and a new delivery system was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that the stent allegedly failed to deploy from the delivery system.Reportedly, the delivery system was removed from the patient without incident, and a new delivery system was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 the specification prior to shipment.No additional complaint has been previously reported for this lot number.Investigation summary: based on the evaluation of the sample returned, the reported failure to deploy the stent could not be confirmed.Even thought the stent was found loaded in the delivery system upon sample receipt, the stent could be deployed on the laboratory table without problems.No damage or device deficiency could be identified.Based on the evaluation results, the reported issue could not be reproduced and the investigation will be closed with inconclusive result.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling applicable it was found that the instructions for use (ifu) sufficiently addressed the potential risk.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.".In regards to accessories the ifus state: 'the bard® lifestar vascular stent system is only compatible with a 0.035¿ (0.89 mm) guidewire.', and 'the 6f delivery system requires a minimum (.) 6f introducer sheath.' based on the ifu supplied with this product, the device is indicated for the treatment of iliac occlusive disease or for the treatment of biliary strictures resulting from malignant neoplasms.

• Brand Name: LIFESTAR BILIARY STENT
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8425809
• Report Number: 9681442-2019-00035
• Device Sequence Number: 19395565
• Product Code: FGE
• UDI-Device Identifier: 04049519005416
• UDI-Public: (01)04049519005416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 09/14/2021
• Device Model Number: VIUS08060
• Device Catalogue Number: VIUS08060
• Device Lot Number: ANCW1977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1