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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT XL VASCULAR STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT XL VASCULAR STENT Back to Search Results
Catalog Number EX051703C
Device Problems Break (1069); Difficult or Delayed Positioning (1157); Misfire (2532); Malposition of Device (2616)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified.(expiry date: 04/2021).
 
Event Description
It was reported that during the stent deployment procedure, the stent allegedly deployed partially.It was further reported that the handle got stuck and the physician was unable to rotate the thumb wheel.Reportedly, the stent got dislodged from the delivery system and it was compressed inside the vessel.The physician performed an emergency bypass by using another graft and withdrew the compressed stent.The patient was reportedly stabilized.
 
Event Description
It was reported that during the stent deployment procedure, the stent allegedly deployed partially.It was further reported that the handle got stuck and the physician was unable to rotate the thumb wheel.Reportedly, the stent got dislodged from the delivery system and it was compressed inside the vessel.The physician performed an emergency bypass by using another graft and withdrew the compressed stent.The patient was reportedly stabilized.
 
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 products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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: the device sample and images were provided for evaluation.Based on the device sample no partial deployment and no deployment difficulty could be confirmed.The system was found in used condition with fully activated thumb slider and without stent; the pusher was found distal of the stent housing indicating complete deployment.However, inside the grip a force transmitting post was found broken which leads to confirmed result for break.The provided images cannot confirm malposition nor partial deployment because of poor resolution.System compatible introducer and guidewire were being used; the lesion was pre dilated.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit.' in regard to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' holding and handling of the system throughout deployment including unpacking and preparation were found sufficiently described in the instructions for use.H10: d4 (expiry date: 04/2021).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.H3 other text : see h10.
 
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Brand Name
LIFESTENT XL VASCULAR STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key11797996
MDR Text Key249749013
Report Number9681442-2021-00301
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,distri
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX051703C
Device Lot NumberANDR3195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Date Manufacturer Received10/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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