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

Device Problem Complete Blockage (1094)

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

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No testing methods were performed since no product information was available.

Event Description

In review of published literature, these findings were noted: hung-lung hsu, chen-ming huang, yin-yin chen, fu-chien hsieh,and jer-shen chen, ¿the sandwich technique with body flossing wire to revascularize left subclavian artery in thoracic endovascular aortic repair¿, annals of vascular surgery 2017; 39: 152¿159, http://dx.Doi.Org/10.1016/j.Avsg.2016.04.016.From april 2014 to april 2015, 20 consecutive patients (14 males and 6 females, mean age 61.4) receiving tevar for acute or chronic thoracic aortic pathologies which need covering the lsa for adequate proximal landing were included.All patients were implanted with gore® viabahn® endoprosthesis in the left subclavian artery as periscope grafts, 15 patients with only one graft and five patients with more than one graft.Seven of 20 patients were implanted with gore® viabahn® endoprosthesis in the left common carotid artery (lcca) as chimney endografts.Total 19 patients had patent sandwiched grafts.It was stated that the patency rate of the sandwiched periscope graft in the thoracic aorta was 95% at a mean follow-up of 9.7 months.The only one (5%) occluded sandwiched periscope graft was found in a (b)(6) female with chronic sternal wound infection and rapid expansion of residual descending aortic dissection at 12-month follow-up after reintervention for a type ia endoleak.This lsa graft might be compressed or kinked during the secondary procedure by the kissing balloon technique over the lcca chimney graft and the extended proximal aortic endograft.No neurological deficit or left upper limb ischemia was noted in the patient and the occluded graft was not addressed.

Manufacturer Narrative

Add the literuture as attachment.(b)(4) additional information about this event was requested but could not be obtained.Without additional information it is impossible to further investigate this event.(b)(4).

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6939712
• MDR Text Key: 89223255
• Report Number: 2017233-2017-00534
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/30/2017; 11/23/2017
• 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
• Patient Age: 70 YR