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

Catalog Number UNK FLUENCY

Device Problem Obstruction of Flow (2423)

Patient Problems Aneurysm (1708); Occlusion (1984); Stenosis (2263)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: walker, j., kaushik, s., hoffman, m., gasper, w., hiramoto, j., reilly, l., & chuter, t.(2019).Long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms.Journal of vascular surgery, 69(2), 341¿347.Doi: 10.1016/j.Jvs.2018.04.074.

Event Description

It was reported in an article from the journal of society for vascular surgery titled " long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms " that complications were examined in a prospective study of 142 patients who underwent thoracoabdominal and pararenal aortic aneurysms endovascular repair using a stent grafts.The presence of a four stiff covered stents probably contributed to the overall stability of the branched stent grafts, however, the downstream end of a stiff, unyielding covered stent traumatizes the relatively soft, flexible, mobile renal artery, causing hyperplasia, stenosis, and occlusion.The status of the patients was not provided.

• 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: 9324528
• MDR Text Key: 166832442
• Report Number: 2020394-2019-04599
• Device Sequence Number: 1
• Product Code: PFV
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other