MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number 0650HYB0605

Device Problem Malposition of Device (2616)

Patient Problems Occlusion (1984); Renal Failure (2041)

Event Date 04/17/2015

Event Type  Injury  

Event Description

During an article review, with the title ¿results of the gore® hybrid vascular graft in challenging aortic branch revascularization during complex aneurysm repair¿, published in the journal annals of vascular surgery in 2015 from nikolaos tsilimparis, md et all, following was noted: a retrospective analysis of 12 patients treated with the gore® hybrid vascular graft was performed.Indication for gore® hybrid vascular graft implantation included difficult access to target vessel and surgeon¿s decision to reduce organ ischemia time during revascularization.The procedures in which the gore® hybrid vascular graft was considered were visceral debranching procedures prior to thoracoabdominal stent-grafting, as well as challenging revascularization of renal and hypogastric arteries.Within a 26-month period 25 gore® hybrid grafts were implanted in 12 patients.Technical success was achieved in all cases.Beside this information, following was reported: in one case, a side branch of the renal artery perfusing a third of the ipsilateral kidney was covered with the stent graft of the gore® hybrid vascular graft, thus resulting in partial infarction of the respective kidney segment without relevant worsening of renal function.

Manufacturer Narrative

Further investigation is being conducted and the information will be included in the final report.

Manufacturer Narrative

Date when partial infarction of the respective kidney segment was observed remains unknown.Therefore date when literature article was accepted will be taken as event date.The review of the manufacturing records verified that this lot met all pre-release specifications.Udi # for lot 10109675: (b)(4).Added literature to report source: w.L.Gore & associates received two lot numbers which were implanted during the procedure (lot # 10109675 and lot # 10120460).According to the physician it is unclear which lot covered a side branch of the renal artery.Therefore gore is submitting a report for each lot reported.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4951932
• MDR Text Key: 6254353
• Report Number: 2017233-2015-00474
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,lit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2014
• Device Catalogue Number: 0650HYB0605
• Device Lot Number: 10109675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• 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: 33 YR