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

Catalog Number	EX100801CD
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2016
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 successful deployment, the stent length was measured to be 120 mm instead of 80 mm.The stent length in vivo was estimated by means of a non-inflated 80 mm balloon.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.No sample was returned.Based on the images provided a stent elongation or incorrect stent length of the used product could not be confirmed.Potential product and non product related factors which may have caused or contributed to the reported issue have been considered.Previous investigations of similar complaints have been reviewed to determine the root cause.An inadvertent movement of the hand during stent release, incorrect holding of the delivery system during stent release, insufficient pre dilatation, highly calcified vessel, patient condition or the vessel anatomy may result into an irregular placement of the stent.In this case no information regarding placement site or the procedure was provided.The stent was deployed correctly and it was an off label use application.Furthermore, a manufacturing related issue was considered.For this product a 100% inspection of the correct stent length was performed during manufacturing and during final inspection prior to release.There is no indication for a mislabeling of the delivery system or the stent.On the basis of the available information and the evaluation of the provided images, a definite root cause for the event reported could not be determined.The ifu states: "verify that the distal and proximal stent radiopaque markers are distal and proximal to the target stricture".In addition, the ifu describes the deployment of the stent sufficiently.Furthermore, the lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Event or Problem Description
It was reported that after successful deployment, the stent length was measured to be 120 mm instead of 80 mm.The stent length in vivo was estimated by means of a non-inflated 80 mm balloon.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: 5811698
• Report Number: 9681442-2016-00206
• Device Sequence Number: 10874346
• Product Code: FGE
• UDI-Device Identifier: 04049519000619
• UDI-Public: (01)04049519000619(17)180129(10)ANAN3622
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K053404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2016

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: 01/29/2018
• Device Catalogue Number: EX100801CD
• Device Lot Number: ANAN3622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2016
• Supplement Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 102