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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to get additional information from the author.As no information related to this complaint has been or will be provided by the author, this event will be closed with the information received.Date the incident occurred is unknown, so the date of publication of the article was used as the incident date.

Event Description

Within the article ¿mid-term results of chimney and periscope grafts in supra-aortic branches in high risk patients¿, published by f.Pecoraro et al, within the european society for vascular surgery, circulated on july 25, 2017, the article results indicates the following: a retrospective analysis, from october 2009 to may 2014, of patients with aneurysms requiring thoracic endovascular aneurysm repair (tevar) with zone 0/1/2 proximal landing in association with at least one chimney and periscope grafts (cpg) in the supra-aortic branches (sab), was conducted.The indication for cpg treatment was a taaa in 7 cases, an arch aneurysm in 16; a descending aneurysm in 14; and an aneurysm extending from arch to the visceral aorta in the remaining four patients, 41 patients were treated in total.26 patients were treated electively and 15 non-electively.59 sabs were treated with the cpg technique: in 29 cases a single cpg was used, in 8 a double, in 2 a triple, and in 4 a quadruple.The proximal landing was in zone 0 in 49% of patients, zone 1 in 17%, and zone 2 in 34%.For the cpg technique a stent graft (hemobahn or viabahn; w.L.Gore & associates, (b)(4), usa) was positioned in the target sab over a rosen (cook medical, in, usa) or amplatz (boston scientific) wire with the support of a sheath.Generally, first the cpg stent grafts, then the aortic stent graft (tag; w.L.Gore & associates) were deployed.After deployment of the cpgs, sheaths were reinserted for stabilisation and for eventual proximal and/or distal stent graft extension.The aortic stent graft was parked and deployed approximately 1 cm distal to the cpg position.Cpgs were oversized 1-2 mm with respect to the target sab.The cpgs and the aortic stent graft were moulded using the kissing balloon technique.Since 2015 all parallel grafts have been primarily reinforced by a corresponding wallstent (boston scientific) relining the entire length over which the cpg could be compressed when running parallel to the aorta.Technical success was achieved in all but 2 cases (95%).Peri-operative complications and neurological events were registered.One patient suffered from a stroke with spinal cord ischaemia.A significant aneurysm sac shrinkage (p<.001) was reported at mean follow-up and no significant aneurysm sac increase (>5 mm).The estimated 2 year survival, freedom from re-intervention, freedom from endoleak, and freedom from branch occlusion were 75%, 77%, 86%, and 96%, respectively.

• 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: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8011881
• MDR Text Key: 125280327
• Report Number: 2017233-2018-00655
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• 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): Other
• Patient Age: 68 YR