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Catalog Number DSF2033 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Atrial Perforation (2511)
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Event Date 03/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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On (b)(6) 2018, the patient underwent endovascular treatment of a thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis.According to the report, during withdrawal of the 20 fr gore® dryseal flex introducer sheath, from the left external iliac artery, the artery ruptured.Reportedly, no anatomical restrictions, other than narrow access vessels, were noted and resistance was not reported during the withdrawal of the introducer sheath.An additional procedure was performed to repair the rupture, whereby a gore® viabahn® endoprosthesis was implanted within the left external iliac artery, and the procedure was concluded with no further adverse events being reported.Final angiography showed exclusion of the aneurysm, repair of the rupture and the patient was reported to have tolerated the procedure.According to the physician, the cause of the rupture was due to the insertion of the 20 fr introducer sheath into the 7.5 mm left external iliac artery.
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Search Alerts/Recalls
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