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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM Back to Search Results
Catalog Number EX062003JL
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(03/2021).The catalog number identified has not been cleared in the u.S.But, it is similar to the lifestent solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified.
 
Event Description
It was reported that after pre-dilatation during treatment via radial artery approach, the vascular stent delivery system allegedly failed to pass through the lesion.It was further reported that an additional dilatation was performed and that the delivery system was again unable to track through the lesion.There was no reported patient injury.
 
Event Description
It was reported that after pre-dilatation during treatment via radial artery approach, the vascular stent delivery system allegedly failed to pass through the lesion.It was further reported that an additional dilatation was performed and that the delivery system was again unable to track through the lesion.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned delivery system the alleged failure to cross the lesion could not be confirmed.The distal section of the system including tip was found in good condition without damage/ deformation indicating crossing difficulty.Images/movies documenting the alleged issue were not provided.The investigation led to an inconclusive evaluation result because the issue could not be re produced; an indication for a manufacturing related issue could not be found.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently addressed the potential risk.The ifu state: 'gain femoral access utilizing a 6 fr (2 mm) or larger introducer sheath.', 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'gain femoral access utilizing a 6 fr (2 mm) or larger introducer sheath.' regarding pta the ifu state: 'predilation of the lesion should be performed using standard techniques.'.H10: d4(03/2021), g4.H11: h3, h6(results, conclusion).H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestent solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified in d2 and g5.H11:section a through f - the information provided by bd 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 bd.
 
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Brand Name
LIFESTENT SOLO VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9210426
MDR Text Key178642071
Report Number9681442-2019-00187
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741112058
UDI-Public(01)00801741112058
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,distri
Type of Report Initial,Followup
Report Date 01/30/2020
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 Catalogue NumberEX062003JL
Device Lot NumberANDQ3828
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Initial Date Manufacturer Received 09/25/2019
Initial Date FDA Received10/18/2019
Supplement Dates Manufacturer Received01/29/2020
Supplement Dates FDA Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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