Catalog Number HT076080 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure to Anastomose (1028)
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Event Date 11/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Analysis-report from third party was received and will be further investigated.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Event Description
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It was reported to gore that patient underwent endovascular treatment for a right-left crossed femoro-femoral bypass with a gore® propaten® vascular graft - thin-walled removable ringed.It was stated that the prosthesis was implanted on (b)(6) 2020 in order to treat an acute ischemia of the left lower limb following the treatment of a type a aortic dissection by open surgery.It was reported that on (b)(6) 2020, after about 2 months, the distal part of the prosthesis was explanted due to a rupture of the distal anastomosis.
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Manufacturer Narrative
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H6 evaluation codes investigation findings 213 refers to the phr-review.A review of the manufacturing records indicated the released portion of the lot met all pre-release specifications.Analysis-report from third party was received and will be further investigated.
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Manufacturer Narrative
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Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin were 5 specimens of gore® propaten® vascular graft fragments and tissue (segments 1-5).The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report and performed in person on-site evaluation of the specimen encompassing both level 1 and level 2.Based on the explant scientist¿s review of the reports, in conjunction with on-site analysis, no additional information is requested.There were no indications of material failure such as suture pull through or suture hole elongation and radial film remained present along the returned fragments.No defects are observed on the anastomosis site and the eptfe membrane does not present any defects.
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Search Alerts/Recalls
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