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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 5F070601C
Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/15/2021
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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products are identified.As the lot number for the device was provided, a review of the device history records 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.Medical device - expiry date: 07/2024.Device not returned.
 
Event Description
It was reported that during a stent placement procedure in the right external iliac artery, the stent was delivered and upon retraction the distal part of the catheter was allegedly noted to be missing.Upon angiogram, the tip of the device was noted to be in the iliac.After several attempts to recover the device another stent was used to block the device component from migrating further.The patient was reported to be in a stable condition.
 
Event Description
It was reported that during a stent placement procedure in the right external iliac artery, the stent was delivered and upon retraction the distal part of the catheter was allegedly noted to be missing.Upon angiogram, the tip of the device was noted to be in the iliac.After several attempts to recover the device another stent was used to block the device component from migrating further.The patient was reported to be in a stable condition.
 
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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent 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.Investigation summary: the sample was returned for evaluation.The distal end of the inner catheter including tip was missing and found to be broken off in the cardan section of the inner catheter.No x-ray images were provided to verify the location of the broken segment.Based on evaluation of the sample returned, breakage of the inner catheter is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the instructions for use supplied with this product the potential issue of resistance during the deployment procedure was found addressed.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." regarding deployment 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 the potential factor of insufficient 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." h10: d4 (expiry date: 07/2024), g3.H11: h6 (method, result).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.
 
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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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12860664
MDR Text Key281141656
Report Number9681442-2021-00602
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120381
UDI-Public(01)00801741120381
Combination Product (y/n)N
Reporter Country CodeBE
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 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5F070601C
Device Lot NumberANFU1053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
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
Patient Outcome(s) Required Intervention;
Patient SexMale
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