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

Catalog Number FEM12040

Device Problems Positioning Failure (1158); Fracture (1260); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  malfunction  

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 patient details.

Event Description

It was reported that during the stent placement procedure for treatment of a stenosis in the subclavian vein distal to the junction of subclavian and brachiocephalic vein via access through a forearm a/v graft, the endovascular stent graft could not be deployed resulting in the breakage of the outer catheter of the delivery system.The device was removed and another stent graft was used to complete the procedure successfully.There was no reported patient injury.

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 the reported failure to deploy the stent graft.The delivery system was found to be in used condition upon sample receipt.Two distal stent graft struts were found to have perforated the distal tip of the outer sheath of the delivery system leading to increased release force and subsequent sheath fracture which made successful stent graft deployment impossible.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 or challenging stent placement site leading to increased friction and subsequent damage to the outer sheath.Reportedly, the target lesion had been pre-dilated.Not using an introducer sheath or the use of an inappropriately sized guide wire also may contribute to the reported event.As reported, difficulties were experienced in inserting the delivery system and resistance was felt during tracking of the system.Insufficient flushing of the device may be another contributing factor to increased friction and subsequent device damage.On the basis of the information available, 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 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." the ifu indicates that an introducer sheath with appropriate inner diameter and a 0.035" (0.89 mm) guide wire are required for the procedure.Also the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." in addition, the ifu states that the device must be flushed with sterile saline.Updated 'eval code & desc - conclusion 1'; evaluation completed.

Event Description

It was reported that during the stent placement procedure for treatment of a stenosis in the subclavian vein distal to the junction of subclavian and brachiocephalic vein via access through a forearm a/v graft, the endovascular stent graft could not be deployed resulting in the breakage of the outer catheter of the delivery system.The device was removed and another stent graft 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5980074
• MDR Text Key: 55718703
• Report Number: 9681442-2016-00249
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639(17)190513(10)ANAS1297
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2019
• Device Catalogue Number: FEM12040
• Device Lot Number: ANAS1297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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
• Patient Age: 57 YR