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

Model Number	5F051203CS
Medical Device Problem Codes	Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
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 not provided; therefore, a review of the device history records could not be performed.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that a vascular stent allegedly would not cross a lesion in a distal fem-pop anastomosis while tracking over a 0.018 guidewire.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: this supplemental mdr is being sent to report the date of event which was identified on (b)(6) 2019.Also, changed the results code from "114 - operational problem identified" to "180 - mechanical problem identified", and added method code "3331 - analysis of production records".Manufacturing review: the lot number was not provided.A review of the device lot history records was not performed.It was not known whether the reported event was possibly caused by a manufacturing issue.Investigation summary: based on the investigation of the returned catheter sample tracking difficulty could be confirmed.The distal end of the tip was found with signs of wear and the stability sheath was found with compressive crinkles which both indicated that increased pushing force was present during insertion and that increased friction occurred at the distal end.Based on the information available the investigation was closed with confirmed result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this event, the potential issue was found addressed, the ifu states: 'the guidewire lumen is designed to accept a compatible 0.035 inch (0.89 mm) guidewire.', and 'insert a guidewire of appropriate length and 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.', and 'always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.', and 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger'.The ifu further states:' if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage before use 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.'.
Event or Problem Description
It was reported that a vascular stent allegedly would not cross a lesion in a distal fem-pop anastomosis while tracking over an 0.018" guidewire.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was not provided.A review of the device lot history records was not performed.It was not known whether the reported event was possibly caused by a manufacturing issue.Investigation summary: based on the investigation of the returned catheter sample tracking difficulty could be confirmed.The distal end of the tip was found with signs of wear and the stability sheath was found with compressive crinkles which both indicated that increased pushing force was present during insertion and that increased friction occurred at the distal end.Based on the information available the investigation was closed with confirmed result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this event, the potential issue was found addressed, the ifu states: 'the guidewire lumen is designed to accept a compatible 0.035 inch (0.89 mm) guidewire.', and 'insert a guidewire of appropriate length and 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.', and 'always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.', and 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger'.The ifu further states:' if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage before use 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.'.
Event or Problem Description
It was reported that a vascular stent allegedly would not cross a lesion in a distal fem-pop anastomosis while tracking over an 0.018" guidewire.Reportedly, another stent was used 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: 7680085
• Report Number: 9681442-2018-00107
• Device Sequence Number: 1383985
• Product Code: NIP
• UDI-Device Identifier: 00801741120657
• UDI-Public: (01)00801741120657
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2019

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: 5F051203CS
• Device Catalogue Number: 5F051203CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 04/30/2019
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/14/2018; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 41