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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT Back to Search Results
Catalog Number VIEL08120
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2023
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure via lower extremity arteries, when the stent was inserted and released, it was measured to be over one hundred and twenty millimeters in length, extending beyond the planned position.It was further reported that because the stent length was longer than the nominal length, healthy tissue was also covered by the stent in addition to the part where it was planned to be placed.The procedure was completed by placing an additional stent inside the elongated stent and then ballooned.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025).H11: section a through f ¿ the information provided 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.
 
Event Description
It was reported that during a stent placement procedure via lower extremity arteries, when the stent was inserted and released, it was measured to be over one hundred and twenty millimeters in length, extending beyond the planned position.It was further reported that because the stent length was longer than the nominal length, healthy tissue was also covered by the stent in addition to the part where it was planned to be placed.The procedure was completed by placing an additional stent inside the elongated stent and then ballooned.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent are identified in d2 and g4.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical sample was not available for evaluation.Provided image demonstrates the deployed stent inside patient including a digital length measurement of 134mm from marker to marker which indicates stent elongation of the 120mm stent.A detailed strut analysis for elongation was not possible due to poor resolution.The vessel was not tortuous/ calcified, and the user pined the grip in place, and removed slack before deployment; the target site was seen between the markers before deployment, and the system was kept straight; the user did not experience difficulty during deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent elongation.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 closely describe holding and handling of the system during deployment; in particular the instructions for use state: 'prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.', and 'deploy the stent using the ¿pin & pull-back¿ technique by slowly pulling back the distal t-luer adapter (f) towards the hand that is pinned in place', and 'the radiopaque markers on the stent must not move during stent deployment.' in regards to access and accessories the instructions for use state: 'the lifestar vascular stent system is only compatible with a 0.035 inch (0.89 mm) guidewire.', and 'the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.', and 'via the femoral route, insert a 0.035 inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion.' in regards to pta the instructions for use state: 'pre-dilatation of the stricture is recommended.' in regards to stent size selection the instructions for use state: 'allow approximately 5 ¿ 10 mm of the stent to extend beyond each end of the stricture.', and 'the lifestar vascular stent experiences length changes less than 10% during deployment if appropriate oversizing is used.' d4 (expiration date: 09/2025).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.Device not returned.
 
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Brand Name
LIFESTAR VASCULAR STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key16944468
MDR Text Key315366318
Report Number9681442-2023-00188
Device Sequence Number1
Product Code NIO
UDI-Device Identifier04049519006529
UDI-Public(01)04049519006529
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P080007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVIEL08120
Device Lot NumberANGW0338
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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