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

Catalog Number FEM09120

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

As the lot number of the subject device has not been provided, a device history record review could not be performed to date.The investigation is currently ongoing.

Event Description

It was reported that the endovascular stent graft failed to deploy in the basilic vein via access through a forearm graft due to the separation of the shaft of the delivery system.The device was removed from the patient without any issues.Another device was used to complete the procedure successfully.There was no reported patient injury.

Manufacturer Narrative

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 all specifications prior to shipment.On the basis of the sample condition the reported failure to deploy and outer catheter fracture could not be confirmed as the stent graft was completely released and the outer sheath showed no breakage.However, the condition of the sample indicates that increased friction affected the delivery system during the attempt to deploy the stent graft.No indications for manufacturing related issues were found.Potential factors which may have contributed to the reported issue have been considered.Previous investigations of similar complaints have been reviewed.Based on the sample evaluation a difficult stent graft deployment was confirmed.The event may have been associated with difficult anatomic conditions, which led to increased friction during deployment.Insufficient flushing of the device could be another contributing factor for the reported event.As reported no introducer sheath was used, which could be also a potential contributing factor.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.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 of the same size.¿ and ¿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.¿ furthermore, the ifu states to do not kink the delivery catheter or use excessive force during delivery to the target lesion and that both ports must be flushed with sterile saline (¿) prior to loading the endovascular system over a guide wire.As the ifu describes, flushing these lumens will also facilitate stent graft deployment.Additionally, the ifu states ¿materials required for the fluency plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)¿.Updated ¿device available for eval?¿.Updated ¿device evaluated¿ and ¿deice returned to mfg?¿.Updated ¿eval code & desc ¿ conclusion¿.

Event Description

It was reported that the endovascular stent graft failed to deploy in the basilic vein via access through a forearm graft due to the separation of the shaft of the delivery system.The device was removed from the patient without any issues.Another device was used to complete the procedure successfully.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: fatma demiral ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5784829
• MDR Text Key: 50107244
• Report Number: 9681442-2016-00199
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2018
• Device Catalogue Number: FEM09120
• Device Lot Number: ANZJ1347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1