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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 5F060603C
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  malfunction  
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 pro code and 510 k number for the lifestent 5f vascular stent system products are identified.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, photos and images were provided for review.The investigation of the reported event is currently underway.Expiry date: 01/2025.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.
 
Event Description
It was reported that during a stent placement procedure through crossover approach, foreign material was allegedly found on the wire.It was further reported that the tip was missing.Reportedly, complete material from the vessels were removed.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 lifestent 5f vascular stent system products that are cleared in the us.The pro code and 510 k number 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.Additional complaints have not been reported for this lot, previously.A review of manufacturing records was not performed.Investigation summary: the physical sample was returned for evaluation.The returned catheter sample was found in used condition without stent and with broken inner catheter at the distal end.Images were provided demonstrating a broken off piece of catheter inside the patient.The investigation confirms that the inner catheter cardan tube was broken inside patient, after deployment.An indication for a process related issue could not be identified.Based on the information available the investigation is confirmed result for inner catheter break.A definite root cause for the reported event 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 instruction 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 instruction for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instruction 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 instruction 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.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 : see h10.
 
Event Description
It was reported that during a stent placement procedure through crossover approach, foreign material was allegedly found on the wire.It was further reported that the tip was missing.Reportedly, complete material from the vessels were removed.There was no reported patient injury.
 
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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 Key14692405
MDR Text Key295795089
Report Number9681442-2022-00180
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120077
UDI-Public(01)00801741120077
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 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5F060603C
Device Lot NumberANGN2077
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
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
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