Model Number 10618 |
Device Problems
Defective Device (2588); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
Injury
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Event Description
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It was reported that stent under expansion and damage occurred.The target lesion was located in the left anterior descending artery.After pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black colored structure present in the middle of the stent delivery system.It was felt that there was an under expansion in the mid portion of the deployed stent, so that segment was post-dilated.It was then noted there was stent malformation and elongation with the length observed as 20mm instead of 16mm as per the labeling.A long des of another company was deployed to complete the procedure.No patient complications were reported.
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Manufacturer Narrative
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Correction: e1: initial reporter first name corrected from h to vs.
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Event Description
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It was reported that stent damage and stent under expansion occurred.The target lesion was located in the left anterior descending artery.After a 6f guiding catheter was inserted and pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black structure present in the middle of the stent delivery system.As he felt that there was an under expansion in the mid portion of the deployed stent, he post-dilated the segment and noticed that there was a malformation and stent elongation occurred and the length was observed to be 20mm instead of 16mm of its labeled length.A long des of another company was deployed to complete the procedure.No patient complications were reported.
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Manufacturer Narrative
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Updated the following fields: d4.Lot number, d4.Expiration date, d4.Unique identifier (udi) #, and h4: device manufacture date.
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Event Description
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It was reported that stent damage and stent under expansion occurred.The target lesion was located in the left anterior descending artery.After a 6f guiding catheter was inserted and pre-dilatation was performed, a 3.5x16mm synergy drug-eluting stent (des) was advanced for treatment.However, during deployment, it was noticed that there was a black structure present in the middle of the stent delivery system.As he felt that there was an under expansion in the mid portion of the deployed stent, he post-dilated the segment and noticed that there was a malformation and stent elongation occurred and the length was observed to be 20mm instead of 16mm of its labeled length.A long des of another company was deployed to complete the procedure.No patient complications were reported.
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Search Alerts/Recalls
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