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

Catalog Number DSF2433

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Perforation (2511); Blood Loss (2597)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: the patient¿s medications include; tylenol, dulcolax, peridex, fentanyl, lopressor, narcan, nitroglycerin, protonix, aspirin, bumex, zyrtec, vitamin d-3, diltiazem, culturelle, synthroid, valsartan, and coumadin.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® dryseal flex introducer sheath instructions for use (ifu), states 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 may result.Further, the ifu states, the 24 fr gore® dryseal flex sheath is intended for insertion into an external iliac artery with a nominal sheath outside diameter of 8.8 mm, as it was reported the patient¿s right external iliac artery measured 6.8 mm in diameter, the 24 fr sheath was oversized and therefore use was outside of ifu.

Event Description

The following information was reported to gore through the (b)(4) study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2018, the patient underwent endovascular treatment of a 57.8 mm descending thoracic aortic aneurysm (zone 2), distal to the left common carotid artery ostium and proximal to the left subclavian artery, with four gore® tag® thoracic branch endoprostheses and a conformable gore® tag® thoracic endoprosthesis.According to the report, resistance was encountered during advancement of the 24 fr gore® dryseal flex sheath, through the 6.8 mm right external iliac artery, however, all aortic devices were reported to have been positioned and implanted without issue.It was reported, due to a high level of concern for iliac injury, the sheath was slowly removed and periodic angiograms were taken to confirm integrity of the right iliac.However, upon withdrawal past the mid portion of the right external iliac artery, the patient¿s blood pressure dropped and angiography confirmed iliac rupture.A total blood loss of 1300 ml was reported, with a blood volume replacement of 1200 ml.The sheath was re-advanced past the rupture in order to stabilize the patient hemodynamically.A cut down was performed on the common right femoral artery and clamping was performed on the internal and distal common iliac arteries.The sheath was then withdrawn into the common femoral artery.A 10 mm non-ringed gore vascular graft was placed and a right ilio-femoral bypass was performed.Reportedly, good blood flow was re-established to the femoral artery.Final angiography confirmed exclusion of the aneurysm, repair of the rupture, and full patency of all devices.The procedure was concluded with no further adverse events reported and the patient tolerated the procedure.

Manufacturer Narrative

Report source - study added.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7549647
• MDR Text Key: 109482304
• Report Number: 3007284313-2018-00165
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Catalogue Number: DSF2433
• Device Lot Number: 17760257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65