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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVM14120
Device Problems Positioning Failure (1158); Fracture (1260); Retraction Problem (1536)
Patient Problems Injury (2348); Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative
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.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.(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 during a stent graft deployment procedure in the iliac, the vascular graft allegedly partially deployed after a procedure of embolization of a hypogastric aneurysm.Therefore, the delivery system was removed, and upon removal, a part of the stent released from the introducer sheath.Reportedly, surgery was necessary to remove the stent for hemostasis, requiring intra-arterial clamping by a balloon and removal of part of the externalized stent, the other part was dilated by a 14mm balloon.Another vascular stent graft delivery system was used and deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure and is currently doing well.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: a stent graft delivery system was received for evaluation.The safety clip was found to be removed and missing.The 2-way stopcock and the tuohy-borst valve were found to be opened.The outer sheath was found elongated and compressed distal to the catheter reinforcement.The inner catheter protruded the distal tip; the distal tip was found slightly damaged which was considered to be not an abnormal deformation after a stent release with increased release force, and adverse event as reported.As reported, a part of the stent graft was removed with surgery; three parts of the stent graft were returned.Fragments of the stent graft were returned; two parts were sections of one stent graft end, based on the tantalum markers.The bigger part of the fractured stent graft was a mid section fragment.An unknown object was also returned, which was neither a component of the delivery system nor of the stent graft.Functional/performance evaluation: a flushing test through the proximal luer port and a patency test with device compatible 0.035'' guide wire was successfully performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: as a result of the investigation performed the complaint was confirmed.The returned parts of the stent graft were found fractured, which indicated that the stent graft was partially released and had to be removed with an additional treatment.The outer sheath was found to be elongated and compressed, which indicated that a high deployment force was present during the deployment attempt.However, a definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Based on the information available 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 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.' the ifu further states that the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.(b)(4).
 
Event Description
It was reported that during a stent graft deployment in the iliac, the vascular stent graft allegedly partially deployed after a procedure of embolization of a hypogastric aneurysm.Upon removal of the vascular stent graft, a section of the stent graft released from the delivery system.Reportedly, surgery was performed to remove the stent graft for hemostasis, requiring intra-arterial clamping by a balloon and removal externalized section of the stent graft.The remaining section of the stent was dilated using a 14mm balloon.Another vascular stent graft delivery system was deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure and is currently doing well.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: a stent graft delivery system was received for evaluation.The safety clip was found to be removed and missing.The 2-way stopcock and the tuohy-borst valve were found to be opened.The outer sheath was found elongated and compressed distal to the catheter reinforcement.The inner catheter protruded the distal tip; the distal tip was found slightly damaged which was considered to be not an abnormal deformation after a stent release with increased release force, and adverse event as reported.As reported, a part of the stent graft was removed with surgery; three parts of the stent graft were returned.Fragments of the stent graft were returned; two parts were sections of one stent graft end, based on the tantalum markers.The bigger part of the fractured stent graft was a mid section fragment.An unknown object was also returned, which was neither a component of the delivery system nor of the stent graft.Functional/performance evaluation: a flushing test through the proximal luer port and a patency test with device compatible 0.035'' guide wire was successfully performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: as a result of the investigation performed the complaint was confirmed.The returned parts of the stent graft were found fractured, which indicated that the stent graft was partially released and had to be removed with an additional treatment.The outer sheath was found to be elongated and compressed, which indicated that a high deployment force was present during the deployment attempt.However, a definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Based on the information available 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 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.' the ifu further states that the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.
 
Event Description
It was reported that during a stent graft deployment in the iliac, the vascular stent graft allegedly partially deployed after a procedure of embolization of a hypogastric aneurysm.Upon removal of the vascular stent graft, a section of the stent graft released from the delivery system.Reportedly, surgery was performed to remove the stent graft for hemostasis, requiring intra-arterial clamping by a balloon and removal externalized section of the stent graft.The remaining section of the stent was dilated using a 14mm balloon.Another vascular stent graft delivery system was deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure and is currently doing well.
 
Event Description
It was reported that during a stent graft deployment in the iliac, the vascular stent graft allegedly partially deployed after a procedure of embolization of a hypogastric aneurysm.Upon removal of the vascular stent graft, a section of the stent graft released from the delivery system.Reportedly, surgery was performed to remove the stent graft for hemostasis, requiring intra-arterial clamping by a balloon and removal externalized section of the stent graft.The remaining section of the stent was dilated using a 14mm balloon.Another vascular stent graft delivery system was deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure and is currently doing well.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: a stent graft delivery system was received for evaluation.The safety clip was found to be removed and missing.The 2-way stopcock and the tuohy-borst valve were found to be opened.The outer sheath was found elongated and compressed distal to the catheter reinforcement.The inner catheter protruded the distal tip; the distal tip was found slightly damaged which was considered to be not an abnormal deformation after a stent release with increased release force, and adverse event as reported.As reported, a part of the stent graft was removed with surgery; three parts of the stent graft were returned.Fragments of the stent graft were returned; two parts were sections of one stent graft end, based on the tantalum markers.The bigger part of the fractured stent graft was a mid section fragment.An unknown object was also returned, which was neither a component of the delivery system nor of the stent graft.Functional/performance evaluation: a flushing test through the proximal luer port and a patency test with device compatible 0.035'' guide wire was successfully performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: as a result of the investigation performed the complaint was confirmed.The returned parts of the stent graft were found fractured, which indicated that the stent graft was partially released and had to be removed with an additional treatment.The outer sheath was found to be elongated and compressed, which indicated that a high deployment force was present during the deployment attempt.However, a definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Based on the information available 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 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.' the ifu further states that the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.
 
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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 Key6699854
MDR Text Key79572518
Report Number9681442-2017-00215
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 foreign,other,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberFVM14120
Device Lot NumberANAY1411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2017
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age87 YR
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