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

Model Number	DSF2465
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Intimal Dissection (1333); Perforation of Vessels (2135)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent an endovascular procedure and it was planned to utilize a gore® tag® conformable thoracic stent graft with active control system to treat a thoracic aortic aneurysm.The gore® tag® conformable thoracic stent graft tgmr404020e component was advanced to the intended location in the descending aorta with the physician actuating first stage deployment.After having deployed the stent for about 3 cm, the deployment line suddenly broke without prior resistance felt when pulling the line.The physician reverted to the backup deployment mechanism but the fiber in the according channel was no longer present.As distal blood flow was now impeded due the device still being closed towards distal, there was a need to solve the situation somewhat quickly.Therefore, the physician decided to use a gore® dry seal flex introducer sheath dsf (24/65) and pulled the device in its current state of deployment back into the sheath with force.When rapidly retracting the sheath out of the patient the common iliac artery was injured at the point of access which subsequently was patched.The procedure then proceeded and a bolton thoracic stent graft was implanted.The patient tolerated the procedure.
Additional Manufacturer Narrative
B3: updated event description.G2: additional selection: foreign.H6: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: code 22: according to the dryseal flex introducer sheath instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) associated medwatch report with this case: 2017233-2021-01648.
Event or Problem Description
On (b)(6) 2021, this patient underwent an endovascular procedure and it was planned to utilize a gore® tag® conformable thoracic stent graft with active control system to treat a thoracic aortic aneurysm.The gore® tag® conformable thoracic stent graft tgmr404020e component was advanced to the intended location in the descending aorta with the physician actuating first stage deployment.After having deployed the stent for about 3 cm, the deployment line suddenly broke without prior resistance felt when pulling the line.The physician reverted to the backup deployment mechanism but the fiber in the according channel was no longer present.It was reported that the physician believed the distal blood flow was now impeded due the device still being closed towards distal, there was a need to solve the situation somewhat quickly.Therefore, the physician decided to use a gore® dry seal flex introducer sheath dsf (24/65) and pulled the device in its current state of deployment back into the sheath with force.When rapidly retracting the sheath out of the patient the common iliac artery was injured at the point of access which subsequently was patched.The procedure then proceeded and a bolton thoracic stent graft was implanted.The patient tolerated the procedure.Reportedly, after having retracted the tgmr404020e component from the patient, the physician opened the endoprosthesis on the backtable to understand what had kept it from deploying.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11276808
• Report Number: 3007284313-2021-01238
• Device Sequence Number: 14375465
• Product Code: DYB
• UDI-Device Identifier: 00733132628407
• UDI-Public: 00733132628407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: DSF2465
• Device Catalogue Number: DSF2465
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Weight: 75