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

Model Number FEM12060

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  Injury  

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 a stent graft deployment procedure, the stent graft was allegedly difficult to deploy due to resistance during deployment.Reportedly, after the successful stent graft deployment, a radiopaque marker detached off the delivery system, entered the patient's vein, and migrated into the patient's lung.An unsuccessful attempt was made to retrieve the detached marker using a snare.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.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 the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been previously reported for this lot number.Investigation summary: stent graft delivery system was returned for evaluation; the stent graft was found to be released and was not enclosed.Based on the evaluation of the sample returned, it could be confirmed that the distal tip of the outer sheath of the stent graft delivery system including radiopaque marker broke off.The outer sheath was found frayed and damaged in the area of the break, indicating that the tip of the device broke off as a consequence of tensile stress in this area.The outer sheath near the handle was found without significant elongation, which would indicate high deployment forces.Based on the sample returned a cause for the reported difficulties to deploy could not be determined.No indication for a manufacturing related failure could be found.The reported migration could not be verified as no x-ray images were provided.Potential factors that could have led or contributed to the event reported have been evaluated.Based on the information available and the evaluation of the sample returned, 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 preparation 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."; "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."; "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)".

Event Description

It was reported that during a stent graft deployment procedure, the stent graft was allegedly difficult to deploy due to resistance during deployment.Reportedly, after the successful stent graft deployment, a radiopaque marker detached off the delivery system, entered the patient's vein, and migrated into the patient's lung.An unsuccessful attempt was made to retrieve the detached marker using a snare.Patient status is unknown.

• 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: 7106876
• MDR Text Key: 94477269
• Report Number: 2020394-2017-01728
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANBQ4723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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 Outcome(s): Life Threatening; Other