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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
Catalog Number 5F061003C
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the lot history 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.No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.Investigation summary: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no images were provided for evaluation.Based on the information available and as no sample was returned for evaluation, 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or larger'.The ifu further states:' if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.'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'.The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified.
 
Event Description
It was reported that during a stent placement procedure in the superficial femoral vessel via a contralateral approach, the stent allegedly failed to cross the predilated lesion.It was further reported that the distal end of the delivery system was broken.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure in the superficial femoral vessel via a contralateral approach, the stent allegedly failed to cross the predilated lesion.It was further reported that the distal end of the delivery system was broken.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot history 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.No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.Investigation summary: based on the investigation of the delivery system returned the reported breakage of the catheter could be confirmed.The reported failure to cross could not be reproduced; due to the damage of the catheter a patency test using a guide wire or an introducer sheath could not be performed.The stent delivery sheath contained a bending pattern, which indicated that the delivery system was in a severely curved configuration.No indication for a manufacturing related issue was found.Based on the information available and the evaluation of the sample returned, 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.Regarding preparation 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.Visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.Prior to use flush the guidewire lumen of the stent system with normal, sterile saline until saline exits the tip of the system." regarding accessories the ifu states: "the guidewire lumen is designed to accept a compatible 0.035 inch (0.89 mm) guidewire."; "insert a guidewire of appropriate length and 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath." (.); "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." the catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified.
 
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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 Key8118553
MDR Text Key129158680
Report Number9681442-2018-00206
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120091
UDI-Public(01)00801741120091
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/07/2019
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
Device Operator Health Professional
Device Expiration Date06/22/2020
Device Catalogue Number5F061003C
Device Lot NumberANCT3578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Initial Date Manufacturer Received 11/02/2018
Initial Date FDA Received11/29/2018
Supplement Dates Manufacturer Received02/06/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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