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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 EX061201C
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (03/2022).Device not returned.
 
Event Description
It was reported that performing an arteriography of the left lower limb for critical ischemia, the device allegedly rubbed in the sheath during deployment.It was further reported that the rubber distal end was no longer in place.There was no reported on patient injury.
 
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 system products that are cleared in the us.The pro code and 510k number for the lifestent xl vascular stent system products is identified in d2 and g5.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 sample was not returned for evaluation and no images were provided.Therefore, no product evaluation could be performed.Based on the information available, the investigation of this issue is inconclusive.A definite root cause for the reported issue could not be determined.Labeling review: in reviewing the labeling supplied with this product, it was found that the instructions for use sufficiently address the potential risks.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 use of accessories the instructions for use states: "the following standard materials may also be required to facilitate delivery and deployment of the lifestent® xl vascular stent system: 6f (2.0 mm) or larger introducer sheath, 0.035¿ diameter guidewire." in addition, the instructions for use states "flush the inner lumen of the device with saline prior to use".H10: d4 (expiry date: 03/2022).H11: section a through f ¿ the information provide by bd represents all 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 : device not returned.
 
Event Description
It was reported that performing an arteriography of the left lower limb for critical ischemia, the device allegedly rubbed in the sheath during deployment.It was further reported that the rubber distal end was no longer in place.There was no reported patient injury.
 
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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 AZ 76227
GM  76227
MDR Report Key10694192
MDR Text Key213506597
Report Number9681442-2020-20005
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 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX061201C
Device Lot NumberANEQ2414
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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