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

Model Number DSF2233

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/26/2022

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2022, this patient underwent emergency thoracic endovascular aortic repair (tevar) for treatment of an acute type b aortic dissection and rupture.The procedure was conducted using two gore® tag® conformable thoracic stent grafts with active control system and two gore® dryseal flex introducer sheaths (dsf).During the procedure, occlusion from the left external iliac artery to common femoral artery was observed.Access vessel damage was attributed to the gore® dryseal flex introducer sheath.A gore®viabahn endoprosthesis and a gore® excluder® aaa iliac extender endoprosthesis were deployed to restore blood flow in the vessel.As reported, the patient tolerated the procedure.The physician stated: it was likely that the dsf has damaged the external iliac artery (eia).There was no particular resistance at the time of insertion.It might be also attributed that the access route was a little narrow.

Manufacturer Narrative

The following patient information was asked, but was not available: weight, date of birth, pre-existing condition and medications as gore was unable to determine which device (s) caused or contributed to the event if any; additional device(s) used during the procedure related to this event include the following: gore® dryseal flex introducer sheath, dsf1233, lot/serial: (b)(4), udi: (b)(4).(b)(4).

Manufacturer Narrative

H6: code 213, no device problem found ¿ a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: code 4315, cause not established - as the device was discarded, and no evaluation of the device could be performed, cause was unable to be established.H6: code 4111, communication/interviews - information was requested on access vessel dimensions but was not made available.Information was also requested on whether or not there was any observed plaque, thrombus or calcification.As reported, these were not observed.D10: additional information from the field indicated that access vessel damage was attributed to the 22 fr gore® dryseal flex introducer sheath only and did not apply to the previously indicated device: gore® dryseal flex introducer sheath, dsf1233, lot/serial: (b)(6), udi: (b)(4).

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13996211
• MDR Text Key: 288499814
• Report Number: 3007284313-2022-01849
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• 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,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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; Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female