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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 SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM Back to Search Results
Model Number 5F051003CS
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2022).
 
Event Description
It was reported that during a stent placement procedure, the inner catheter was broke inside the patient after deploying the stent.It was further reported that the broken particles removed with the help of snare.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure, the inner catheter was broke inside the patient after deploying the stent.It was further reported that the broken particles removed with the help of snare.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed.No additional complaint has been reported for this lot number; however another complaint was reported for a similar issue by the same customer.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 delivery system was returned for evaluation.The distal segment of the inner catheter was found broken.Based on information available and the evaluation of the sample returned the reported break of the inner catheter is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant instructions for use the potential issue 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instructions for use states: "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and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 increased deployment forces the instructions for use 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." h10: d4 (expiry date: 08/2022), g3.H11: h6 (method, result, conclusion).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 : see h10.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key10947671
MDR Text Key225112223
Report Number9681442-2020-20057
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120640
UDI-Public(01)00801741120640
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5F051003CS
Device Catalogue Number5F051003CS
Device Lot NumberANET2455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Date Manufacturer Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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