MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM09060

Device Problems Positioning Failure (1158); Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: 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 the specification prior to shipment.No additional complaint has been reported for this lot number previously.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported deployment issue could be confirmed.The distal stent graft marker were found released and one strut perforated the catheter tip which, which led to the impossibility to deploy the stent graft any further.Therefore, as a result of the investigation performed the complaint is confirmed.However, based on the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.Labeling review: based on the lot number provided the following version of the instructions for use (ifu) was supplied with this product which is currently valid.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk.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." regarding the anatomy of the placement site the ifu states: "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." regarding the use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)".Furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment." (expiry date: 08/2021).

Event Description

It was reported that during a right arm a/v fistula procedure the endovascular stent graft allegedly failed to deploy from the delivery system.Reportedly, the delivery system was removed from the patient without incident and another same size endovascular stent graft device was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8392703
• MDR Text Key: 137934887
• Report Number: 2020394-2019-00172
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008547
• UDI-Public: (01)04049519008547
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM09060
• Device Catalogue Number: FEM09060
• Device Lot Number: ANCV0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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: 75 YR
• Patient Weight: 64