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

Model Number DSF2433

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rupture (2208)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Code "other" was selected as the medical device was discarded at facility.Return not possible.A severe injury, illness or impairment which requires hospitalization or medical intervention.Use of an additional or alternative device was required to achieve optimal outcome.Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device.A component whose function is to facilitate the insertion of a particular device.The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.The investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device was discarded at facility.The device either functioned as intended or a problem was not found.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

Event Description

The following information was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment of a thoracic aortic aneurism using two gore® tag® conformable thoracic stent graft with active control systems and gore® dryseal flex introducer sheath (dsf) with stenting in left subclavian artery using bare stent, express 8 mm - 57 mm.Dsf2433 was used for a left common femoral artery access.After all devices were implanted as planed, when dsf was removed, the access vessel was ruptured.An occlusion balloon was inserted from the right side and blocked below the renal artery.Vitals are stable.Additionally, two gore® viabahn® endoprostheses with heparin bioactive surface (vbx) were implanted from the left external iliac artery to just above the left femoral head.However the vessel was damaged up to the dsf insertion area and could not be covered by the vbxs.The left common femoral artery was repaired by anatomizing the distal end of the vbx, bxa083901j, with propaten 7 mm.The distal end of the vbx was compressed due to anastomosis with propaten.Additionally vbx was implanted across the anastomosis.Hemostasis and adequate flow were confirmed and the procedure was completed.The patient tolerated the procedure.The physician stated that resistance was felt when inserting the dsf, which may have caused the rupture.The vessel were fragile.Reportedly, the diameter of the access vessel was around 7.4 mm to 8.7 mm.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: 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: 13017605
• MDR Text Key: 282326781
• Report Number: 3007284313-2021-01706
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2021
• 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: 89 YR
• Patient Sex: Female