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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
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT Back to Search Results
Catalog Number 5F050303C
Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/15/2021
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 that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2024).
 
Event Description
It was reported that during a stent placement procedure, the catheter of the stent delivery system allegedly got stuck in the patient and detached.It was further reported that catheter needs to be removed by surgery.The patient status was unknown.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the stent delivery system was received for evaluation.The distal end of the inner catheter was found broken off and missing.Based on x-ray images provided by the customer, the segment was found stuck inside the patient¿s vessel in the popliteal artery.Several repeating kinks at a regular interval could be found at the cardan tube, as well as on the stent sheath, indicating the passage of tight radiuses during the placement of the delivery system.Based on the condition of the sample no indication that a manufacturing related issue caused the reported issue could be found.Based on information available and the evaluation of the sample the reported break of the inner catheter is confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the instructions for use supplied with this product the potential issue was found addressed.The instructions for use states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding deployment force the instructions for use states: "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." regarding the potential factor of insufficient pre dilation the instructions for use states: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire." h10: d4 (expiry date: 01/2024), g3 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.
 
Event Description
It was reported that during a stent placement procedure, the catheter of the stent delivery system allegedly got stuck in the patient and detached.It was further reported that catheter needs to be removed by surgery.The patient status was unknown.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key12292425
MDR Text Key265558498
Report Number9681442-2021-00429
Device Sequence Number1
Product Code NIP
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 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5F050303C
Device Lot NumberANFN1104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Initial Date Manufacturer Received 07/15/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received08/13/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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