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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR AND BILIARY STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR AND BILIARY STENT Back to Search Results
Catalog Number EX061203C
Device Problem Fracture (1260)
Patient Problems Injury (2348); Obstruction/Occlusion (2422)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
An image was provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(expiry date: 06/2020).
 
Event Description
It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.
 
Event Description
It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent xl vascular stent product that is cleared in the us.The pro code for the lifestent xl vascular stent product is identified in d2.Manufacturing review: the lot history record of this lot was 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: one image of the x-ray screen was provided for evaluation; the image demonstrated the placed stent inside the superficial artery (sfa) in one plane; a strut structure evaluation was not possible due to poor resolution which led to an inconclusive evaluation result.Based on new information available it was not known to which complaint the images belong which also leads to an inconclusive evaluation result.Based on review of the provided image the reported stent fracture could not be confirmed.A definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu describe the stent deployment procedure by stating: 'confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.(.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum.(.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' balloon pre and post dilation was addressed: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' the ifu further state: 'cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture.'.
 
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Brand Name
LIFESTENT STENT SYSTEM
Type of Device
VASCULAR AND BILIARY STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9913831
MDR Text Key187058069
Report Number9681442-2020-00071
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001463
UDI-Public(01)04049519001463
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,foreig
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX061203C
Device Lot NumberANCT2422
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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