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 FLUENCY PLUS VASCULAR STENT GRAFT
  • 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 FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL14120
Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2017
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 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 stent graft was allegedly unable to deploy; therefore, the vascular stent graft delivery system was removed without incident.Reportedly, the delivery system was exchanged for another and the procedure was completed.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing related cause was performed; the lot history 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 additional complaint has been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure was confirmed.The stent graft was found partially released and the outer sheath was found to be elongated and fractured, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.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 labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." regarding the anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure." furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment." the catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified.
 
Event Description
It was reported that the stent graft was allegedly unable to deploy; therefore, the vascular stent graft delivery system was removed without incident.Reportedly, the delivery system was exchanged for another and the procedure was completed.There was no reported patient injury.
 
Event Description
It was reported that the stent graft was allegedly unable to deploy; therefore, the vascular stent graft delivery system was removed without incident.Reportedly, the delivery system was exchanged for another and the procedure was completed.There was no reported patient injury.
 
Manufacturer Narrative
The previously submitted supplemental emdr inaccurately reported the g4 date of 1/12/17.The g4 date on the supplemental should have been reported as 1/12/18.Manufacturing review: a manufacturing related cause was performed; the lot history 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 additional complaint has been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure was confirmed.The stent graft was found partially released and the outer sheath was found to be elongated and fractured, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.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 labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." regarding the anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure." furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment." the catalog number identified in section d4 has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified in d2 and g5.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLUENCY PLUS VASCULAR STENT GRAFT
Type of Device
VASCULAR STENT GRAFT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key7084862
MDR Text Key94143608
Report Number9681442-2017-00304
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2018
Device Catalogue NumberFVL14120
Device Lot NumberANZG1203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
-
-