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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 5F061003C
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/10/2022
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 system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified in common device name and pma/510k.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.(expiration date: 07/2025).
 
Event Description
It was reported that during a stent placement procedure in distal superficial femoral artery to popliteal artery and the tibiofibular trunk, via left antegrade femoral artery approach, the stent assembly was allegedly broken and detached into three segments.It was further reported that two segments were removed with slings.Reportedly, surgical intervention was performed to retrieve the remaining segment.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 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products 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 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 sample was returned for evaluation.The returned sample was found in used condition without stent, which reportedly had been deployed inside patient.The inner catheter cardan tube was found broken three times at the distal end which leads to confirmed result for inner catheter cardan tube break and detachment.The stent was placed proximal to another stent for extension, the vessel was not tortuous but medium calcified, 5f introducer with 0.014¿ guidewire were used for access, and the lesion was pre dilated.The system was correctly held at the stability sheath, the user did not experience difficulty/ force increase during deployment.Based on the information available the investigation is closed with confirmed result for inner catheter break and subsequent detachment.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.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 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 states: '5f (1.67 mm) or larger introducer sheath (¿); 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiration date: 07/2025).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.
 
Event Description
It was reported that during a stent placement procedure in distal superficial femoral artery to popliteal artery and the tibiofibular trunk, via left antegrade femoral artery approach, the stent assembly was allegedly broken and detached into three segments.It was further reported that two segments were removed with slings.Reportedly, surgical intervention was performed to retrieve the remaining segment.The current status of the patient is 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
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 Key16119650
MDR Text Key306881141
Report Number9681442-2022-00385
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120091
UDI-Public(01)00801741120091
Combination Product (y/n)N
Reporter Country CodeGM
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 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5F061003C
Device Lot NumberANGU0330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2023
Was Device Evaluated by Manufacturer? Yes
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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