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 LIFESTAR 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 LIFESTAR VASCULAR STENT SYSTEM Back to Search Results
Catalog Number VIES10120
Device Problems Positioning Failure (1158); Kinked (1339); Failure to Advance (2524); Misfire (2532)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2017
Event Type  malfunction  
Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.
 
Event Description
It was reported that prior to a stent deployment procedure in the biliary artery, the vascular stent allegedly became stuck while being loaded over the guidewire.Reportedly, another vascular stent delivery system was used to complete the procedure.There was no reported patient contact.
 
Manufacturer Narrative
Manufacturing review: the lot records have been 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.Investigation summary: based on the investigation of the returned catheter sample a failure to advance over the guidewire or a difficult wire advancement could not be confirmed.During evaluation a system compatible guidewire could be easily inserted and fully advanced without difficulty, and the stent could be further deployed easily at a low force level.A stuck guidewire was not part of the return.The safety clip was not attached to the system upon sample receipt and the stent was partially released; it was not known when and how this partial deployment was caused.The alleged stuck guidewire could not be reproduced and the investigation will be closed with inconclusive result.No indication could be found for a process related issue.Based on the information available and the evaluation of the sample returned a definite root caused could not be identified.Labeling review: in reviewing the labeling applicable it was found that the instructions for use (ifu) sufficiently describe the potential issue.The ifu states: 'visually inspect the bard lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.(.) take care to avoid unnecessary handling, which may kink or damage the delivery system.' and 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' furthermore, the ifu demands for sufficient flushing of the delivery system through both luer lock adapters.In regards to guidewire, the ifu states: 'the bard® lifestar¿ vascular stent system is only compatible with a 0.035¿ (0.89 mm) guidewire.' the intended application represents an off label use of the device; the bard lifestar vascular stent system is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries.(b)(4).
 
Event Description
It was reported that prior to a stent deployment procedure in the biliary artery, the vascular stent allegedly became stuck while being loaded over the guidewire.Reportedly, another vascular stent delivery system was used to complete the procedure.There was no reported patient contact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFESTAR VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT SYSTEM
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6847321
MDR Text Key85155495
Report Number9681442-2017-00259
Device Sequence Number1
Product Code NIO
UDI-Device Identifier04049519006680
UDI-Public(01)04049519006680
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P080007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/31/2019
Device Catalogue NumberVIES10120
Device Lot NumberANAU3808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2016
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 Age45 YR
Patient Weight70
-
-