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

Catalog Number DSF1833

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Patient medications: zyloprim, aspirin, lipitor, colchicine, florinef, lortab, meclizine, proamatine the review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the device was discarded, and no evaluation of the device could be performed, cause was unable to be established.

Event Description

On (b)(6) 2019 the patient underwent endovascular repair of an abdominal aortic aneurysm using a gore® dryseal flex sheath as an accessory in the procedure.It was reported that the patient had a previously implanted cook medical iliac graft (type unknown) located in the right common iliac artery.The patient's right internal iliac artery was previously coiled and covered.The gore® dryseal flex sheath was advanced on the patient's left side.Tortuosity of the patient's access vessel was noted.No resistance upon sheath advancement was noted.An rlt281416 gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component was advanced.The trunk of the device was successfully deployed.Resistance was noted upon attempted removal of the gore® dryseal flex sheath.Reportedly it was suspected that the leading end of the sheath had become lodged within the struts of the previously implanted cook medical graft.Removal of the sheath was attempted again and it was reported that the gore® dryseal flex sheath split into two pieces.Reportedly no excessive force was used during attempted removal.The trailing end of the sheath was successfully removed.The leading end of the sheath remains in the patient's right common iliac artery.Reportedly the physician performed aorto-uni-iliac stent grafting and a femoral to femoral bypass with ligation of the patient's iliac artery.There were no further reported issues.The patient tolerated the procedure.

Event Description

See h10/11 for updated/corrected event information.

Manufacturer Narrative

B.5.Event description updated/corrected.It was initially reported that the gore® dryseal flex sheath was advanced on the patient's left side.Supplemental information was received to clarify that the gore® dryseal flex sheath was advanced on the patient's right side, thereby becoming lodged within the proximal struts of the previously implanted cook medical graft located in the patient's right common iliac artery.All other reported information was confirmed to be accurate, and therefore remains unchanged.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8770024
• MDR Text Key: 150396607
• Report Number: 3007284313-2019-00195
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: 00733132630042
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Catalogue Number: DSF1833
• Device Lot Number: 18713585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10/11 FOR LIST OF MEDICATIONS.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 121