MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Model Number	5F051003CS
Medical Device Problem Codes	Difficult to Remove (1528); Misfire (2532); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
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 return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that during a stent placement procedure intended for a calcified right femoral artery via access through the left femoral artery, the stent allegedly partially deployed approximately two centimeters using the thumbwheel deployment wheel.It was further reported that there was alleged difficulty removing the delivery system and the guidewire became stuck in the system.Angioplasty was performed 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.Based on the evaluation of the returned sample it could be confirmed that the user could only partially deploy the stent and that the guide wire got stuck.Inside the grip the catheter including inserted guidewire were found kinked which made a complete deployment impossible and which indicated that excessive release force must have been present.It was concluded that increased friction was present during deployment leading to force increase, lumen deformation, kink, and subsequent deployment failure.The stuck guidewire was considered a subsequent event caused by force increase and lumen deformation.An indication for a manufacturing related issue could not be identified.Based on the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review:in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' in regards to pta, the ifu states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.(expiry date 06/2020).(device code 3, method 1, results 1, conclusion 1).
Event or Problem Description
It was reported that during a stent placement procedure intended for a calcified right femoral artery via access through the left femoral artery, the stent allegedly partially deployed approximately two centimeters using the thumbwheel deployment wheel.It was further reported that there was alleged difficulty removing the delivery system and the guidewire became stuck in the system.Angioplasty was performed to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8182102
• Report Number: 9681442-2018-00221
• Device Sequence Number: 16602486
• Product Code: NIP
• UDI-Device Identifier: 00801741120640
• UDI-Public: (01)00801741120640
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 5F051003CS
• Device Catalogue Number: 5F051003CS
• Device Lot Number: ANCT1160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR