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

Model Number FEL10120

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event 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 the endovascular stent graft allegedly only partially deployed, as there was no more room to continue with the pin and 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 device was used to complete the procedure.There was no reported patient injury.

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.The review showed that no remarkable incidents occurred during the manufacturing process.Investigation summary: on the basis of the returned stent graft delivery system, the alleged partial deployment was confirmed as the stent graft was found completely loaded in the system.Additionally, the reported impossibility to deploy the stent graft was also confirmed.The outer sheath was found to be elongated which indicated that increased friction affected the delivery system during attempt of stent graft deployment and subsequently resulted in an outer sheath fracture.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 use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)" and "the use of an appropriately sized introducer sheath is recommended." furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." and "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.".

Event Description

It was reported that during deployment the endovascular stent graft allegedly only partially deployed, as there was no more room 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 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: 6925630
• MDR Text Key: 89649438
• Report Number: 2020394-2017-01290
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008271
• UDI-Public: (01)04049519008271
• 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: 12/19/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2020
• Device Model Number: FEL10120
• Device Catalogue Number: FEL10120
• Device Lot Number: ANBR1726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• 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: 87 YR