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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 5F061203C
Device Problems Break (1069); Difficult or Delayed Positioning (1157); Retraction Problem (1536)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 11/24/2019
Event Type  Injury  
Manufacturer Narrative
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.The lot number for the device was provided.The device history records are currently under review.The device and an image/photo have been returned for evaluation.The investigation is currently underway.
 
Event Description
It was reported that during a stent placement procedure in a highly calcified distal superficial femoral artery (sfa), additional force was allegedly used to deploy the stent, at which point a piece of the distal part of the catheter allegedly broke off and traveled downstream the artery.It was further reported that the detached segment could not be removed, therefore, the patient was taken to emergency vascular surgery to remove the segment.The patient was reportedly hemodynamically stable post procedure.
 
Event Description
It was reported that during a stent placement procedure in a highly calcified distal superficial femoral artery (sfa), additional force was allegedly used to deploy the stent, at which point a piece of the distal part of the catheter allegedly broke off and traveled downstream the artery.It was further reported that the detached segment could not be removed, therefore, the patient was taken to emergency vascular surgery to remove the segment.The patient was reportedly hemodynamically stable post procedure.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were 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.Investigation summary: based on the investigation of the returned sample, and images provided break of the inner catheter at the distal end could be confirmed.The system was returned in activated state without stent as the stent had been released inside patient.The distal end of the inner catheter was found broken, as reported.An indication for a manufacturing related issue could not be found.Based on the investigation the reported issue was closed as confirmed.A definite root cause for the reported event could not be determined.Labeling review: based on the lot number reported the following instructions for use (ifu) were supplied with the product.In reviewing the relevant ifu the potential issue was found addressed.The ifu state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' regarding deployment force the ifu state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' under materials required the ifu state '5f (1.67 mm) or larger introducer sheath', and '0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.In this case system compatible introducer and guidewire were being used.The ifu further state: '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.' in regards to pta the ifu state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.'.H10: d10; g4; h6 (device 2976 material deformation).H11: h3; h6 (results, conclusion).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 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 Key9490204
MDR Text Key177151375
Report Number9681442-2019-00243
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120107
UDI-Public(01)00801741120107
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2021
Device Catalogue Number5F061203C
Device Lot NumberANDT4080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Date Manufacturer Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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