MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number	FEM08080
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further procedural details.
Event or Problem Description
It was reported that during stent graft placement for treatment of a ruptured vessel in the brachiocephalic via access through the left upper arm, the sleeve of the introducer ruptured.Another stent graft of the same brand and size was used to complete the procedure successfully.There was no reported patient injury.
Additional Manufacturer Narrative
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 all specifications prior to shipment.There is no indication for a manufacturing-related failure.The evaluation of the returned device confirmed that the deployment mechanism had been actively used and that the stent graft could not be deployed.The outer sheath was found to be elongated and fractured indicating the presence of high release force during the attempt to release the stent graft.An introducer sheath was not part of the sample return thus a relation between the subject device and the introducer sheath used during the procedure could not be evaluated.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with a difficult vessel anatomy leading to increased friction and subsequent sheath fracture.In this case, the target anatomy was not tortuous or calcified and the lesion had been pre-dilated.Reportedly, the introducer sheath broke during advancement which may have led to increased friction and the reported deployment failure, however, as the introducer sheath was not part of the sample return, no further evaluation could be performed.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.The ifu indicates that both ports of the device must be flushed with sterile saline prior to use.Also the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." in addition, the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) 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" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, the ifu indicates that an introducer sheath of appropriate inner diameter is required for the procedure.The ifu further 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." the reported application represents an off-label use of the device.As per ifu, the fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.
Event or Problem Description
It was reported that during stent graft placement for treatment of a ruptured vessel in the brachiocephalic via access through the left upper arm, the sleeve of the introducer ruptured.Another stent graft of the same brand and size was used to complete the procedure successfully.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6519028
• Report Number: 9681442-2017-00153
• Device Sequence Number: 13650266
• Product Code: PFV
• UDI-Device Identifier: 04049519008509
• UDI-Public: (01)04049519008509(17)191104(10)ANAY0772
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2019
• Device Model Number: FEM08080
• Device Catalogue Number: FEM08080
• Device Lot Number: ANAY0772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 88