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

Model Number FEM14040

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: review of manufacturing records was not required, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were 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.Investigation summary: a stent graft delivery system was returned for evaluation.On the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The stent graft was found partially released and the outer sheath was found elongated, 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 is confirmed.A definite root cause for the reported event could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during a stent graft placement , the stent allegedly failed to deploy.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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9181671
• MDR Text Key: 162022158
• Report Number: 2020394-2019-03864
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008684
• UDI-Public: (01)04049519008684
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2021
• Device Model Number: FEM14040
• Device Catalogue Number: FEM14040
• Device Lot Number: ANCQ1363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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: 58 YR
• Patient Weight: 106