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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM Back to Search Results
Model Number 5F051203CS
Device Problems Failure to Advance (2524); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
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 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.
 
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 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.
 
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 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.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key7680085
MDR Text Key113750299
Report Number9681442-2018-00107
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120657
UDI-Public(01)00801741120657
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5F051203CS
Device Catalogue Number5F051203CS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
Patient Weight41
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