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

Catalog Number 0650HYB0605

Device Problems Break (1069); Sticking (1597); Activation, Positioning or Separation Problem (2906)

Patient Problem Tissue Damage (2104)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: (b)(6) 2015 gore® hybrid vascular graft lot #13687094.A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The devices were returned to w.L.Gore & associates for investigation.Submitted in this event was/were 2 incomplete gore® hybrid vascular grafts.The examination found no definitive anomalies attributable to the manufacture of the devices.The returned devices match the reported description of the devices in the event.Information provided reported the use of a ¿12fr.Peel away sheath¿ used for both grafts.Instructions for use (ifu) table 1 recommends use of an 11 fr peal/tear-away sheath size for a labeled nitinol reinforced section diameter of 6mm.Device 1: partial expansion of the proximal end, with the middle of the nitinol reinforced section(nrs) still constrained, along with blunt end fibers, is consistent with attempted deployment of the constraint delivery system(cds) from a proximal to distal direction.Ifu states, ¿deployment of the nitinol reinforced section will occur from the tip of the delivery constraint toward the non-nitinol reinforced section¿ if instructions are followed.Body tape delamination and distal migration is consistent with extraction of an expanded device from a vessel.No major tape delamination, bent or broken struts, or visible interactions/entanglements were observed suggesting the deployment line(dl) was free from any obstructions inhibiting deployment.

Event Description

On (b)(6) 2015, a patient was being implanted with two gore hybrid vascular grafts in a debranching procedure in the superior mesenteric artery and the left renal artery.The grafts were both inserted through a 12 fr peel-away sheath.It was reported to gore that as the nitinol portion of the first device was being deployed into the superior mesenteric artery, the deployment line broke.The device was partially deployed.The arteriotomy was extended, the nitinol portion was removed and a regular anastomosis was performed.It was reported to gore that as the nitinol portion of the second device was being deployed into the renal artery, the deployment line got stuck after two-thirds of the device deployed.The procedure was completed by extending the arteriotomy, cutting the nitinol portion off and performing a regular anastomosis.

Manufacturer Narrative

Initial reporter: complainant was a distributor.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5308435
• MDR Text Key: 33834612
• Report Number: 2017233-2015-00895
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

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
• Device Expiration Date: 06/11/2016
• Device Catalogue Number: 0650HYB0605
• Device Lot Number: 12745252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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: 58 YR