Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM Back to Search Results
Catalog Number 5F051001C
Device Problems Break (1069); Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.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.(b)(4).The information provided by bard 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 bard.
 
Event Description
It was reported that the vascular stent was allegedly unable to deploy from the delivery system during treatment in the femoral artery via a direct iliac access.Reportedly, the device was removed without incident from the patient and exchanged for another to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the delivery system could only partially deploy the stent.The deployment wheel was found fully activated but a force transmitting catheter at the proximal end was found broken which made a complete stent deployment impossible; at the position of break a kink deformation was visible.Furthermore, in the distal section a kink pattern was found on the distal catheter indicating a rough bending radius and friction increase.Increased friction during deployment was considered as reason for breakage of a force transmitting component and subsequent partial stent deployment.Another inner catheter component was found broken in approximately the same position which was considered a consequence of handling after the partial stent deployment.Based on the available information and the evaluation of the returned sample the complaint was confirmed.However, based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu 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.' the catalog number has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.
 
Event Description
It was reported that the vascular stent was allegedly unable to deploy from the delivery system during treatment in the femoral artery via a direct iliac access.Reportedly, the device was removed without incident from the patient and exchanged for another to complete the procedure.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key7516708
MDR Text Key108360359
Report Number9681442-2018-00061
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741119835
UDI-Public(01)00801741119835
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue Number5F051001C
Device Lot NumberANBV2618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Initial Date Manufacturer Received 04/18/2018
Initial Date FDA Received05/15/2018
Supplement Dates Manufacturer Received06/01/2018
Supplement Dates FDA Received06/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight50
-
-