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

Catalog Number DSL2428J

Device Problems Positioning Failure (1158); Sticking (1597); Failure to Advance (2524)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Shock (2072); Rupture (2208)

Event Date 04/02/2015

Event Type  Death  

Event Description

On (b)(6) 2015, the patient underwent endovascular repair of a thoracic aortic aneurysm with two conformable gore® tag® thoracic endoprostheses (tgu373720j/13304126, tgu313115j/13430575).Prior to the implantation of the devices, a left axillary artery ¿ right axillary artery bypass surgery was performed.Post-implantation images showed a type iii endoleak from the junction of the two ctag devices.The physician determined to monitor the endoleak and concluded the procedure.On (b)(6) 2015, a conformable gore® tag® thoracic endoprosthesis (tgu404015j/13518805) was implanted using a gore® dryseal sheath (dsl2428j/13150960) to reline the junction area of the existing ctag devices to treat the persisting type iii endoleak.The physician also elected to implant another conformable gore® tag® thoracic endoprosthesis (tgu454520j/13399700) at the proximal neck to prevent a type i endoleak.After the successful insertion of the dsl2428j, a delivery catheter of the tgu454520j was inserted through the sheath, but it would not advance over the tortuous abdominal aorta.The physician withdrew the delivery catheter and performed the pull-through technique with a radifocus to straighten the abdominal aorta and reinserted the tgu454520j again.As the delivery catheter advanced up to the aortic arch, the catheter got stuck.The physician attempted to change the radifocus to a stiffer lunderquist guidewire.However, the radifocus could not be retracted.Thus, the physician deployed the device inside the existing device intentionally.The radifocus and the delivery catheter were withdrawn together successfully.While inserting a new lunderquist guidewire, the patient¿s blood pressure dropped rapidly.The angiography showed the rupture of the right external iliac artery.Although the physician attempted to occlude the aorta endovascularly using a balloon catheter, it was unsuccessful due to the absence of a guidewire.The patient was in shock status, and cpr was performed as an open abdominal repair was performed to stop bleeding.However, the patient expired during the surgery.It was reported that during the advancement of the delivery catheter over the patient¿s tortuous abdominal aorta, the dsl2428j began to come down.Thus the physician pushed the dsl2428j up without the dilator since the delivery catheter of the tgu454520j was inside.The physician suspected that this push may have caused the rupture and it was not realized for a while, contributing to the massive blood loss and the death.The diameter of the right external iliac artery measured less than 8mm.(24fr od=9.2mm).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturing evaluation performed.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® dryseal sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.The ifu also states "do not attempt sheath advancement or withdrawal without guidewire and dilator in place.Major bleeding, vessel damage, or serious injury to the patient, including death, may result.".

Manufacturer Narrative

Lot/serial:(b)(4) = (b)(4).

• Brand Name: GORE® DRYSEAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL DEER VALLEY B/P; 24416 n. 19th avenue; phoenix AZ 85085
• Manufacturer Contact: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4738633
• MDR Text Key: 5884058
• Report Number: 3007284313-2015-00048
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: DSL2428J
• Device Lot Number: 13150960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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: 88 YR