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

Model Number	EX080603CD
Medical Device Problem Codes	Difficult to Remove (1528); Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during a stent placement procedure, the stent deployment mechanism allegedly jammed before the stent was fully deployed.It was further reported that upon removal of the remaining segment of the delivery system using a hemostat, the stent was separated from the delivery system and elongated.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was not reported so that a review of lot history documentation was not possible.It was therefore not known whether the reported event was potentially related to production.Investigation summary: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no x-ray images were provided for evaluation.Based on the information available a definite root cause for the event reported could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.The use of the biliary device in the vascular system represents an off label use.In the ifu the deployment procedure was found sufficiently described.Furthermore, the ifu and packaging labels demand for a 6f (2.0 mm) or larger introducer sheath.
Event or Problem Description
It was reported that during a stent placement procedure, the stent deployment mechanism allegedly jammed before the stent was fully deployed.It was further reported that the partially released stent could be separated from the delivery system by using a hemostat, which caused the stent to elongate.There was no reported patient injury.
Additional Manufacturer Narrative
After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Manufacturing review: the lot number was not reported so that a review of lot history documentation was not possible.It was therefore not known whether the reported event was potentially related to production.Investigation summary: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no x-ray images were provided for evaluation.Based on the information available the investigation is closed with inconclusive result.A definite root cause could not be determined.The reported event represents an off label use of the device.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.The use of the biliary device in the vascular system represents an off label use.In the ifu the deployment procedure was found sufficiently described.Furthermore, the ifu and packaging labels demand for a 6f (2.0 mm) or larger introducer sheath.
Event or Problem Description
It was reported that during a stent placement procedure, the stent deployment mechanism allegedly jammed before the stent was fully deployed.It was further reported that the partially released stent could be separated from the delivery system by using a hemostat, which caused the stent to elongate.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 7987472
• Report Number: 2020394-2018-01924
• Device Sequence Number: 148665
• Product Code: FGE
• UDI-Device Identifier: 04049519000404
• UDI-Public: (01)04049519000404
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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 Model Number: EX080603CD
• Device Catalogue Number: EX080603CD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 02/26/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/27/2018; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR