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

Model Number	5F061503CS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that during a stent placement procedure in a calcified sfa via a contralateral approach, the tip of the device allegedly broke during successful deployment.It was further reported that a new access site was made distally to remove the broken tip.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure in a calcified sfa via a contralateral approach, the tip of the device allegedly broke during successful deployment.It was further reported that a new access site was made distally to remove the broken tip.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 shows 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: based on the investigation of the returned catheter sample a break of the inner catheter at the distal end could be confirmed.The system was returned in activated state without stent as the stent had been released inside patient.The distal end of the inner catheter was found fractured.The stent housing was found with a one-sided kink pattern which may indicate tortuous anatomy.An indication for a process related issue could not be found.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant ifu the potential issue was found addressed.The ifu states: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the ifu further 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.' in regards to deployment force 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.' in regards to accessories the ifu states: 'gain (.) access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger' and 'insert a guidewire of appropriate length and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter (.)'.

• 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: 8305861
• Report Number: 9681442-2019-00013
• Device Sequence Number: 154683
• Product Code: NIP
• UDI-Device Identifier: 00801741120206
• UDI-Public: (01)00801741120206
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5F061503CS
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANCR2663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 54