MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Event Description

The following article was reviewed: ¿open and endovascular repair of popliteal artery aneurysms¿ (benjamin del tatto et.Al, ann vasc surg 2018; 50: 119¿127, published online on marche 1, 2018).The purpose of this study was to report midterm outcomes of open repair (or) or endovascular repair (er) of popliteal artery aneurysms (paas) and assess if outcomes of patients have changed in the endovascular era.This monocentric and retrospective study included all consecutive patients treated for paa between january 2004 and december 2016.Before 2010, all patients underwent or, but er was available since 2010, and the choice between o.R or er was made on the basis of clinical presentation and preoperative morphological assessment.Er was performed in 50 limbs of 39 patients with gore® viabahn® endoprosthesis.The mean treated lesion length in er was 18.1 cm (range 10 - 28 cm).The mean number of devices used was 2.1.In 13 cases (26.0%), 1 device was used; in 26 cases (52.0%), 2 devices were used; and in 11 cases (22.0%), 3 devices were used.Mean device diameter was 8.6 mm (range 5 - 13 mm).Mean oversizing rate was 13.6 % (range 11 - 18%).The article states that duplex ultrasonography follow-up depicted 1 case of stent fracture treated by another stenting (e-luminexx 12 _ 40 mm, bard, murray hill, nj, usa).

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8163941
• MDR Text Key: 130325220
• Report Number: 2017233-2018-00765
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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): Required Intervention
• Patient Age: 70 YR