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

Catalog Number RRT07070080L

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

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further investigation is being conducted and the information will be included in the final report.

Event Description

The patient presented with a left limb claudication where a gore-tex® vascular graft was implanted as a femoropopliteal bypass on (b)(6) 2016.On (b)(6) 2016, after about 37 days, the gore-tex® vascular graft was explanted due to staphylococcus aureus and streptococcus pyogenes infections.The patient is doing well following the procedure.The clinical history of the patient notes a left maxillary sinus tumor treated with surgery on (b)(6) 2016, and chemotherapy.

Manufacturer Narrative

The review of the sterilization records verified that this lot met all pre-release specifications.The gore-tex® vascular graft was returned to (b)(4), independent laboratory, for investigation.Submitted in formalin was a gore-tex® vascular graft ¿ thin-walled removable ringed fragment.The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant investigator (ei) at w.L.Gore & associates reviewed the report.The following is a summary of the ei observations: tissue present: yes.Graft fragment appears to be have mutifocal areas of glossy pink tissue adhered to the ablumen.Graft material color transitions from pink to light tan.Complete fixation of the specimen does not appear to have been achieved.Dr.Delay reported a significant amount of povidone-iodine was used during the explant which may lend to the device discoloration.Luminal tissue deposition cannot be determined via mode of analysis.From gross images the graft fragment appears to have been transected at both poles.One pole has a green suture ligation present which was likely placed during explant procedure for device removal.The graft appears to have an irregular diameter at multiple points; the cause cannot be determined via images and analysis provided.Metal surgical instruments were used during the evaluation of the returned specimen, as is evident from the photographs in the report.Request for additional analysis: no.Reason: material disruptions are consistent with surgical instruments used during the explant process.Based on review of the report in conjunction with the conclusion of the (b)(4) investigators, no additional analysis is requested.

• Brand Name: GORE-TEX® 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 ; 9285263030
• MDR Report Key: 6408768
• MDR Text Key: 70060791
• Report Number: 2017233-2017-00127
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: RRT07070080L
• Device Lot Number: 14677872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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: 59 YR
• Patient Weight: 61