Catalog Number TBCL2648C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 02/17/2021 |
Event Type
Death
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Manufacturer Narrative
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Conclusion code 1:22: according to the gore® tri-lobe balloon catheter instructions for use, adverse events which may require intervention include, but are not limited to: vascular dissection and death.
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Event Description
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The following was reported to gore: on (b)(6) 2021 a patient underwent aortic endovascular treatment as a subject in the ssb11-02 pivotal clinical trial.The treatment included the use of a gore® tri-lobe balloon catheter in the ascending thoracic aorta.On (b)(6) 2021 an ascending thoracic aortic dissection was discovered and the patient expired.
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Manufacturer Narrative
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H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
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Manufacturer Narrative
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D1/d2: dqy common device name catheter, percutaneous.H6: component code 419 balloon.
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Search Alerts/Recalls
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