Model Number 1804275-18 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported the procedure was to treat a lesion in the posterior descending artery.The 2.75x18mm xience skypoint stent delivery system (sds) was advanced to the target lesion.However, during the first inflation to 14 atmospheres to 30 seconds, the balloon did not hold pressure, there was a hole in the balloon.The stent was deployed at the intended site and the delivery system was removed without issue.A 3.0x15 mm nc trek was used to post dilate the skypoint stent.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported material rupture was confirmed.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.The investigation was unable to determine a conclusive cause for the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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