MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0); INTRODUCER, CATHETER

Model Number	DSL2428
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	01/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Per the gore® dryseal sheath instructions for use, 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.
Event or Problem Description
It was reported to gore that on (b)(6) 2020, a conformable gore® tag® thoracic endoprosthesis was to be implanted during treatment of a thoracic aorta dissection.When the device was advanced to the target lesion through the gore dryseal sheath with hydrophilic coating(dsl2428), the physician initiated the deployment line, after the whole deployment line was pulled out, the device expanded successfully, only except that about 3-4cm of the proximal end of the device couldn¿t expand.The physician tried to use the balloon(gore tri-lobe balloon catheter) to dilate but the balloon didn¿t go through.Then the patient was transferred to the cardiac surgery department for surgical intervention.The physician found the device and cut the sewn deployment sleeve.The device expanded and the delivery catheter was retracted.The patient¿s vital pressure and other vital signs were stable.Then the abdominal aortic dissection and left iliac artery dissection were seen under the angiography.The lifetech38-34-200(local brand) stent was implanted in descending aorta.It was seen that the right common iliac artery was ruptured under the angiography because of patient's excessive tortuous vessel and the sheath remained inside the patient's body for long time.Then gore vascular graft (sbt1601d)was implanted by immediate open surgery.The patient¿s blood pressure and heart rate are normal after the procedure, and the blood oxygen is low.
Additional Manufacturer Narrative
B5: the event description was updated.H6: the patient code was updated.
Event or Problem Description
It was reported to gore that on (b)(6) 2020, a conformable gore® tag® thoracic endoprosthesis was to be implanted during treatment of a thoracic aorta ulcer.When the device was advanced to the target lesion through the gore® dryseal sheath with hydrophilic coating (dsl2428), the physician initiated the deployment line, after the whole deployment line was removed, the device expanded successfully, except for about 3-4cm of the proximal end of the device.The physician tried to use a balloon (gore® tri-lobe balloon catheter) to dilate the stent graft but the balloon wasn¿t able to advance through the device.The patient was then transferred to the cardiac surgery department for surgical intervention.The physician cut down to gain access to the device and cut the sewn deployment sleeve.The device expanded and the delivery catheter was retracted.The patient¿s vital pressure and other vital signs were stable.At that time, an abdominal aortic dissection and left iliac artery dissection were seen under angiography.A lifetech38-34-200( local brand) stent was implanted in the descending aorta.It was seen under angiography that the right common iliac artery was ruptured when the gore® dryseal sheath was retracted from the patient's body.It was reportedly due to the fact the sheath remained inside of the patient's body for an extended period.A gore® vascular graft (sbt1601d) was then implanted by immediate open surgery.The patient¿s blood pressure and heart rate were normal after the procedure, and the blood oxygen was low.It was reported that there was adequate iliac and femoral access and no reported tortuosity during the procedure.It was reported by the physician that the patient experienced a cerebral infarct.The patient was never discharged from the hospital and stayed in icu until the patient expired on (b)(6).The cause of the death is unknown and the sequence of events between the index procedure and the death on post-op day 20 is also unknown.
Additional Manufacturer Narrative
H6.Conclusion code was corrected.
Additional Manufacturer Narrative
B5: describe event or problem: updated.
Event or Problem Description
It was reported to gore that on jan 14, 2020, a conformable gore® tag® thoracic endoprosthesis was to be implanted during treatment of a thoracic aorta ulcer.When the device was advanced to the target lesion through the gore dryseal sheath with hydrophilic coating (dsl2428), the physician initiated the deployment line ,after the whole deployment line was pulled out , the device expanded successfully ,only except that about 3-4cm of the proximal end of the device couldn¿t expand.The physician tried to use the balloon(gore tri-lobe balloon catheter) to dilate but the balloon didn¿t go through.Then the patient was transferred to the cardiac surgery department for surgical intervention.The physician found the device and cut the sewn deployment sleeve.The device expanded and the delivery catheter was retracted.The patient¿s vital pressure and other vital signs were stable.Then the abdominal aortic dissection and left iliac artery dissection were seen under the angiography.The lifetech38-34-200 (local brand) stent was implanted in descending aorta.It was seen that the right common iliac artery was ruptured under the angiography because of patient's excessive tortuous vessel and the sheath remained inside the patient's body for long time.Then gore vascular graft (sbt1601d) was implanted by immediate open surgery.The patient¿s blood pressure and heart rate are normal after the procedure, and the blood oxygen is low.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9663466
• Report Number: 3007284313-2020-00026
• Device Sequence Number: 2784280
• Product Code: DYB
• UDI-Device Identifier: 00733132619993
• UDI-Public: 00733132619993
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/18/2020

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: 12/13/2020
• Device Model Number: DSL2428
• Device Catalogue Number: DSL2428
• Device Lot Number: 17557745
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/07/2020; 03/31/2020; 06/18/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 68 YR