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

Model Number DSF1233

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.

Event Description

The following information was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis and non-gore balloon catheter for abdominal aortic aneurysm and the right common iliac aneurysm.As a concomitant procedure, embolization of the right internal iliac artery and inferior mesenteric artery were performed.After deploying the trunk - ipsilateral leg endoprosthesis, the first (pla320400j/22128535) and the second aortic extender endoprosthesis (pla320400j/22188171), type iiia endleak was noted.The third and fourth aortic extender endoprosthesis (pla280300j/22492806) were deployed but the endoleak was not resolved.It was reported that the left renal artery was unintentionally covered by the fourth aortic extender endoprosthesis.In addition, retrograde aortic dissection from the central edge of the fourth aortic extender endoprosthesis and the right renal artery dissection were observed.Percutaneous angioplasty in the ostium of the left renal artery, and stent deployment in the right renal artery were performed.The flow to both renal arteries was still weak.After deployment of all devices, access rupture of the left femoral artery was observed.Patch plasty (5400-c:-additional procedure other - other/unknown) was performed.The patient tolerated the procedure.The physician suggested that touch up using non-gore balloon catheter was too strong.Multiple touching up might have contributed to the entry at the proximal end of the cuff.The dissection would have extended to the right renal artery.On (b)(6) 2020, abdominal ultrasound scan showed endoleak.The patient underwent reintervention.Type iiia endoleak was confirmed during the procedure.Four additional aortic extender endoprosthesis were deployed.The amount of endoleak decreased, but it was not resolved.The patient will be monitored.The physician stated that the proximal neck was tightly tortuous.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11147836
• MDR Text Key: 226054888
• Report Number: 3007284313-2021-01224
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: DSF1233
• Device Catalogue Number: DSF1233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• Date Device Manufactured: 08/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR