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

Model Number	5F070403CS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
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.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample a break of the outer catheter could be confirmed.The stability sheath was found with a split on a length of approximately 5mm.A failure to unlock and a failure to deploy could not be confirmed; during evaluation the stent could be successfully deployed by using the grip.Therefore, the investigation will be closed as confirmed for damage/ material deformation.An indication for a manufacturing related issue could not be found.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 ifu for this product the potential issue was found addressed.The ifu states: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.', 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back', and 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit'.
Event or Problem Description
It was reported that during a stent placement procedure on the mid-sfa through femoral access, a damaged component prevented the safety lock to move, therefore preventing the deployment wheel to rotate, and the stent allegedly failed to deploy.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESSTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8040178
• Report Number: 9681442-2018-00195
• Device Sequence Number: 1302759
• Product Code: NIP
• UDI-Device Identifier: 00801741120312
• UDI-Public: (01)00801741120312
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 11/05/2018

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 Expiration Date: 04/13/2020
• Device Model Number: 5F070403CS
• Device Catalogue Number: 5F070403CS
• Device Lot Number: ANCR1321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 110