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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT Back to Search Results
Catalog Number EX062003L
Device Problems Fracture (1260); Misfire (2532); Malposition of Device (2616)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/13/2023
Event Type  Injury  
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent solo 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 return of the sample is pending.However, an image and video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).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 in the superficial femoral artery via the crossover femoral artery access, after a few centimeters of the deployment, the mechanism got stuck and the stent allegedly was allegedly could not be deployed any further.It was further reported that the physician tried to withdraw the partially opened stent with the whole deployment mechanism to the sheath, which was not possible in the beginning; however, after advancing the sheath further to the stent, the stent could be covered with the sheath.Furthermore, approximately one centimeter of the distal part of the stent was already too deployed, and therefore allegedly got stuck just outside of the sheath and then allegedly got teared off.Reportedly, the distal end of the stent which had fractured upon removal allegedly got landed in the common iliac artery.The procedure was completed by using another device.The current status of the patient is unknown.
 
Event Description
It was reported that during a stent placement procedure in the superficial femoral artery via the crossover femoral artery access, after a few centimeters of the deployment, the mechanism got stuck and the stent allegedly was allegedly could not be deployed any further.It was further reported that the physician tried to withdraw the partially opened stent with the whole deployment mechanism to the sheath, which was not possible in the beginning; however, after advancing the sheath further to the stent, the stent could be covered with the sheath.Furthermore, approximately one centimeter of the distal part of the stent was already too deployed, and therefore allegedly got stuck just outside of the sheath and then allegedly got teared off.Reportedly, the distal end of the stent which had fractured upon removal allegedly got landed in the common iliac artery.The procedure was completed by using another device.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot# were reviewed with special attention to the manufacturing and inspection of this 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 issues.Investigation summary: the delivery system was not returned for evaluation.Provided image demonstrates a fractured stent end inside the iliac section.Provided x-ray video demonstrates a partially deployed stent in the sfa; although a deployment failure is not visible on the video the investigation leads to confirmed result for partial stent deployment leading to stent fracture upon removal, and misplacement of the fractured stent end in the iliac artery.The vessel reportedly was not tortuous/ calcified, a 6f introducer was in use, and a force increase was not felt during deployment attempt.Based on the investigation of the provided information, the investigation is closed as confirmed for partial deployment and stent fracture upon removal.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.Holding and handling of the system throughout deployment was found sufficiently described, in particular the instructions for use state : 'gently hold the stability sheath at or proximal to the orange marking and maintain it straight and under tension throughout the procedure.' the instructions for use further 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.' regarding pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' under required materials the instructions for use state : '(.) 6f (2.0 mm) or larger introducer sheath, 0.035 inch (0.89 mm) diameter guidewire(.).' 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 : device not returned.
 
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Brand Name
LIFESTENT SOLO 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 Key18086487
MDR Text Key327556090
Report Number9681442-2023-00365
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519003900
UDI-Public(01)04049519003900
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P070014
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 11/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX062003L
Device Lot NumberANGT1539
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2023
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
Patient Outcome(s) Required Intervention;
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