Catalog Number 1012449-12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Date 11/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
The device was not returned for evaluation.
A review of the lot history record could not be conducted because the lot number was not provided.
The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) as a known patient effect.
A conclusive cause for the reported patient effect and the relationship to the product, if any, could not be determined and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
The 2.
8 x 19 mm graftmaster stent delivery system referenced is filed under a separate manufacturing report number.
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Event Description
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It was reported that the patient underwent a coronary stenting procedure, treating severe calcification of the entire proximal to mid to distal right coronary artery (rca).
Rotational atherectomy was performed and a perforation was noted in the mid rca.
A trek balloon dilatation catheter was advanced to the perforation and inflated, with an improvement in extravasation; however, extravasation continued.
A 2.
75 x 12 mm xience alpine stent was implanted just distal to the perforation and a 2.
8 x 19 mm graftmaster stent delivery system (sds) was advanced; however, blood was noted in the inflation line and a balloon tear was noted, possibly from vessel plaque and calcification or possibly from stent struts of a previously implanted stent.
The graftmaster sds was removed from the anatomy without difficulty.
Additional pre-dilatation was performed using a 3.
0 x 12 mm nc trek, and a dissection occurred.
An nc trek was then advanced to the dissection and inflated, treating the dissection and further dilating the vessel.
A 3.
5 x 19 mm graftmaster was then deployed, sealing the perforation.
Post dilatation was performed and additional stents implanted.
Final angiography noted no residual stenosis and no evidence of a dissection.
No additional information was provided.
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Search Alerts/Recalls
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