MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	DSF1245
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral leg endoprosthesis), four gore® excluder® aaa endoprostheses (contralateral leg endoprostheses), two gore® excluder® iliac branch endoprostheses (iliac branch component and internal iliac component).Before endoprostheses were implanted, the right internal iliac artery was coil embolized as planned.A 18fr gore® dryseal flex introducer sheath was inserted from the left side and the gore® excluder® iliac branch endoprosthesis (iliac branch component) was delivered.Then, the proximal of the iliac branch component was deployed.A 12fr gore® dryseal flex introducer sheath (dsf1245) was inserted from the right side and the cannulation to the left internal iliac artery was success.Ballooning was performed to the origin of the left internal iliac artery because it was narrow.Then, the internal iliac component was deployed.The external iliac leg of the iliac branch component was also deployed.Afterwards, the gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral leg endoprosthesis) was delivered and proximal of the endoprosthesis was deployed.The angulation and reposition of the proximal of trunk were performed.The dsf1247 was changed to the dsf1233 and the cannulation of the contralateral side was success.Then, the ipsilateral leg of the trunk ipsilateral leg endoprosthesis was deployed.The contralateral leg endoprosthesis (plc271000j) was implanted as bridging device between gore® excluder® conformable aaa endoprosthesis and the gore® excluder® iliac branch endoprosthesis.Three gore® excluder® aaa endoprostheses (plc121400j) were implanted in the right limb.After the sheaths were removed and evar was concluded, it was noticed that the pulse of the right limb was not well.Angiography was performed and there was no flow at the distal of the right dorsalis pedis artery and the right plantar artery.A micro catheter was inserted into ata and pta and urokinase and prostaglandin were injected.After a short time, the angiography, the doppler and the palpation revealed the blood flow was improved.The patient tolerated the procedure.The physician suggested the following: the descending aorta to the proximal neck was shaggy.This case was complicated because the abdominal aorta and the neck was severe tortuous and ibe devices were implanted.The blood flow of the right peripheral artery was interrupted due to a small thrombus might have been scattered.However, it is unknown when it occurred.Reportedly, the proximal neck was severe tortuous (about 90°), so the reposition was performed and the 12fr sheath was delivered from the right common iliac artery with lots of thrombus to the left to implant ibe device.
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device was discarded at facility.Return not possible.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Emdr section h6 e code was corrected.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17487959
• Report Number: 3007284313-2023-02693
• Device Sequence Number: 7293710
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: 00733132628117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2025
• Device Catalogue Number: DSF1245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male