Catalog Number 1012580-16 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional graftmaster device referenced in b5 is filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a perforation of a lesion in the mid left anterior descending (mlad) artery.The 2.8x19mm graftmaster covered stent was being inserted into a 5.5french (f) guide liner when the shaft of the delivery system was noted to be bent and stent could not be deployed so it was removed undeployed and intact.Another 2.8x16mm graftmaster covered stent could not pass the distal left main after being inserted into a 5.5french (f) guide liner.The stent was removed intact.Another 2.5mm stent was used to complete the procedure.The use of the graftmaster covered stents did not cause or contribute to complications or adverse events.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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H6: medical device problem code: improper or incorrect procedure or method (guiding catheter / sheath selection).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the 2.80x16 graftmaster covered stent was inserted into a 5.5 french (f) guide liner and met resistance.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use (ifu) specifies: appropriate guiding catheter(s) ¿ 7f / 0.074" id for 4.50 ¿ 4.80 mm diameter graftmaster rx, or 6f / 0.068" id for 2.80 mm ¿ 4.00 mm diameter graftmaster rx.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported difficult to advance/position could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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It was reported that the procedure was to treat a perforation of a lesion in the mid left anterior descending (mlad) artery.The 2.8x19mm graftmaster covered stent was being inserted into a 5.5french (f) guide liner when the shaft of the delivery system was noted to be bent and stent could not be deployed so it was removed undeployed and intact.Another 2.8x16mm graftmaster covered stent could not pass the distal left main while inserting into a 5.5french (f) guide liner.The stent was removed intact.Another 2.5mm stent was used to complete the procedure.The use of the graftmaster covered stents did not cause or contribute to complications or adverse events.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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