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

Model Number	EX061503CS
Medical Device Problem Codes	Difficult to Remove (1528); Misfire (2532); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.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.(b)(4).
Event or Problem Description
It was reported that during a stent placement procedure in a tortuous and heavily calcified sfa, it was allegedly difficult to track the delivery system through the anatomy to the target lesion.It was further reported that the stent allegedly partially deployed approximately three millimeters.The stent along with the guidewire were reportedly removed together, and another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: a stent delivery system was returned for evaluation.Based on the evaluation of the returned sample a positioning issue could be confirmed.Based on the condition of the sample and the information available it is considered that increased friction led the device compatible hydrophilic guide wire becoming stuck in the delivery system which subsequently led to the partially deployed stent.The shipping lock was found to be removed upon sample receipt, which may have contributed to the partial stent deployment.No indication could be found for a manufacturing related issue.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 supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: "flush the inner lumen of the device with saline prior to use".Furthermore, the ifu states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." and "examine the stent and delivery system device for any damage." the steps of the stent deployment procedure is described in the ifu.Also the ifu states that the shipping lock should be removed after the stent system was introduced to the target lesion and before the stent is ready to be deployed.
Event or Problem Description
It was reported that during a stent placement procedure in a tortuous and heavily calcified sfa, it was allegedly difficult to track the delivery system through the anatomy to the target lesion.It was further reported that the stent allegedly partially deployed approximately three millimeters.The stent along with the guidewire were reportedly removed together, and another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8074514
• Report Number: 9681442-2018-00201
• Device Sequence Number: 16725657
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• 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): 12/20/2018

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: EX061503CS
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANCQ4692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113