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 FVM08120
Device Problems Positioning Failure (1158); Difficult to Remove (1528); Misfire (2532)
Patient Problem Thrombus (2101)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a review of manufacturing records was not required, as no additional complaint has been reported for this lot.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 all specifications prior to shipment.Investigation summary: the catheter sample was not returned, and images have not been provided so that an evaluation was not performed.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the ifu states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' in regard to removal difficulty the ifu state: 'remove the flexible deployment system over the guide wire (.) if resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath'.Potential complications, such as 'bleeding at the side of catheter placement' and 'thrombosis' were found included.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 during a stent graft deployment procedure in the right external iliac artery via access through the right common femoral, the stent graft allegedly partially deployed a few centimeters.It was further reported that during removal of the partially deployed stent graft, the puncture site increased in size with thrombus.Therefore, another device was used to cover the external iliac and common femoral and complete the procedure.The patient was reportedly stable post procedure.
 
Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not required, as no additional complaint has been reported for this lot.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 all specifications prior to shipment.Investigation summary: based on the investigation of the returned delivery system it was confirmed that the user could only partially deploy the stent graft.The system was returned in used condition with partially deployed implant; the outer sheath was found elongated and fractured which made a successful deployment impossible.It was concluded that increased friction affected the system when the user tried to deploy the implant.A manufacturing related issue could not be identified.Images documenting puncture site increase have not been provided.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the ifu states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' in regard to removal difficulty the ifu state: 'remove the flexible deployment system over the guide wire (.) if resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath'.Potential complications, such as 'bleeding at the side of catheter placement' and 'thrombosis' were found included.H10: g4; h6 (device- 1260 fracture).H11: d10; h3; h6 (method, results).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.
 
Event Description
It was reported that during a stent graft deployment procedure in the right external iliac artery via access through the right common femoral, the stent graft allegedly partially deployed a few centimeters.It was further reported that during removal of the partially deployed stent graft, the puncture site increased in size with thrombus.Therefore, another device was used to cover the external iliac and common femoral and complete the procedure.The patient was reportedly stable post procedure.
 
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 Key8669176
MDR Text Key147031459
Report Number9681442-2019-00072
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145650
UDI-Public(01)00801741145650
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Catalogue NumberFVM08120
Device Lot NumberANCU1493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Initial Date Manufacturer Received 04/18/2019
Initial Date FDA Received06/04/2019
Supplement Dates Manufacturer Received08/16/2019
Supplement Dates FDA Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient Weight71
-
-