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

Catalog Number DSL2428

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intimal Dissection (1333); Aortic Dissection (2491); Vascular Dissection (3160)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The root cause of the femoral artery damage could not be determined with the information provided.According to the gore® dryseal sheath with hydrophilic coating 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.The ifu cautions do not attempt to advance or withdraw the introducer sheath or dilator if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient.

Event Description

On (b)(6) 2017, the patient presented with a penetrating aortic ulcer (pau) within the descending thoracic aorta that was treated with two gore® tag® conformable thoracic stent graft with active control system during an emergency case.It was stated that the pre-implant ct that was received from a different hospital did not show the iliac and femoral arteries.Therefore a doppler ultrasound scan was performed and it seemed that the accesses vessels were appropriate for a 24 fr sheath.A 24 fr gore® dryseal sheath was inserted from the right side after the right femoral artery cut-down.Due to a not adequate femoral artery diameter, it was also not possible to advance the sheath to the intended position after several attempts.Due to this, it was realized that femoral artery was damaged and the physician repaired it promptly with the implantation of two gore® viabahn® endoprostheses.The implant was concluded by using a new 24fr gore® dryseal sheath that was advanced through both gore® viabahn® endoprostheses.Two gore® tag® conformable thoracic stent graft were implanted successfully.The patient was in good general condition at the end of the procedure.

• Brand Name: GORE® DRYSEAL 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: 7043522
• MDR Text Key: 92463564
• Report Number: 3007284313-2017-00279
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121234
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: DSL2428
• Device Lot Number: 15859907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• 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: 66 YR
• Patient Weight: 73