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

Model Number FEM09100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

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.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 deployment, using the pin and pull process, the endovascular stent graft allegedly only partially deployed as there was no more room between the catheter and the handle to continue with the pin & pull action in order to fully deploy the stent graft.Therefore, the delivery system was removed with the partial deployed stent without incident.Reportedly, another delivery system was used in order to successfully complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing related cause was performed.The lot history records were 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.There was no manufacturing anomalies or changes which may have caused or contributed to the reported event.No additional complaints have been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, a deployment failure was confirmed.The outer sheath was found to be elongated and fractured, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.Furthermore, the outer sheath was found perforated by stent graft strut, which made a stent graft deployment impossible.As a result of the investigation performed the complaint was confirmed.However, based on the available information 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 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." (b)(4).

Event Description

It was reported that during deployment, using the pin and pull process, the endovascular stent graft allegedly only partially deployed as there was no more room between the catheter and the handle to continue with the pin & pull action in order to fully deploy the stent graft.Therefore, the delivery system was removed with the partial deployed stent without incident.Reportedly, another delivery system was used in order to successfully 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: 6909466
• MDR Text Key: 88034522
• Report Number: 9681442-2017-00276
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008561
• UDI-Public: (01)04049519008561
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2018
• Device Model Number: FEM09100
• Device Catalogue Number: FEM09100
• Device Lot Number: ANZF2102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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
• Patient Age: 39 YR