Model Number 1804350-38 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.
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Event Description
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It was reported that the procedure was to treat an unspecified lesion.Post stent implantation of a xience stent, worsening heart failure was noted.This was resolved in an unspecified manner.No additional information was provided.
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Event Description
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Subsequent to the initial medwatch report, the following information was provided: the patient presented to the hospital experiencing an st elevation myocardial infarction (mi).The xience stent was implanted to treat the lesion causing the mi.On (b)(6) 2021, the patient experienced poor oxygenation and pulmonary congestion, treated with infusion therapy.The patient was diagnosed with heart failure.There was no device malfunction or adverse event associated with the implanted xience stent.The course of treatment was good and the patient was discharged on (b)(6) 2021.No additional information was provided.
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Manufacturer Narrative
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This complaint has been captured as a non-complaint product experience as there was no device malfunction or patient effect associated with the device; thus, investigation is not required.B3: date of event.D6a: implant date.H6: health effect - clinical code 4446 - removed.H6: health effect - impact code - 4614 - removed.H6: medical device problem code 2993 - removed.
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Search Alerts/Recalls
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