MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF1433

Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problems Death (1802); Exsanguination (1841); Perforation of Vessels (2135)

Event Date 09/19/2018

Event Type  Death  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the instructions for use (ifu) of the gore® dryseal flex introducer sheath, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma, bleeding, blood loss and death.

Event Description

On (b)(6) 2018, the patient underwent emergent endovascular repair of a ruptured right common iliac artery aneurysm using gore® excluder® aaa endoprostheses.Since the patient¿s right external iliac artery had been occluded and the patient had a history of femoro-femoral bypass procedure, the physician planned to perform an aorto-uni-iliac (aui) procedure to exclude the rupture site.The physician embolized the right internal iliac artery with vascular plugs and attempted to advance a 14-fr gore® dryseal flex introducer sheath (dsf1433/17736260) from the left side to deploy a contralateral leg component in the abdominal aorta.However, the patient¿s left common iliac artery was tortuous and it was difficult to advance the sheath over the tortuous portion, and while several attempts were made to manipulate the sheath, the rupture site became enlarged.It was reported that the sheath manipulation could have caused or contributed to the enlargement of the rupture site, making bleeding from the rupture site get worse.The physician exchanged the 14-fr sheath with a 12-fr sheath and deployed a contralateral leg component in the patient¿s abdominal aorta.Then, an iliac extender component was implanted for distal extension of the contralateral leg component and five aortic extender components as well as a non-gore manufactured endoprosthesis were deployed for proximal extension of the contralateral leg component to the renal arteries.Intra-procedure imaging did not reveal endoleaks, but the patient¿s abdomen was expanded due to increasing amount of bleeding out of the vessel.Additionally, bowel ischemia was suspected, and the patient suffered from hypotension and atrial fibrillation.The physician performed surgical abdominal drainage and defibrillation, but the patient¿s condition did not recover.The patient expired on the same day.Reportedly, an autopsy was not performed and no further information was available.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7932782
• MDR Text Key: 122614157
• Report Number: 3007284313-2018-00278
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Catalogue Number: DSF1433
• Device Lot Number: 17736260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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): Death
• Patient Age: 76 YR