Catalog Number UNK XIENCE SKYPOINT |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported in a general comment that the physicians are not satisfied with the performance of the xience skypoint and the radial force is not strong enough needing to perform additional post dilatation at higher pressures.
There was no adverse patient (b)(6) and there was no clinically significant delay in the procedure.
No additional information was provided.
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Manufacturer Narrative
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Date of event has been estimated.
The unique device identifier (udi) is unknown because the part number and lot number were not provided.
Implant date has been estimated.
The device was not returned for evaluation.
A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.
The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, the subsequent treatment appears to be related to the operational context of the procedure.
There is no indication of a product quality issue with respect to manufacture, design or labeling.
Na.
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Manufacturer Narrative
|
Date of event has been estimated.
The unique device identifier (udi) is unknown because the part number and lot number were not provided.
Implant date has been estimated.
The device was not returned for evaluation.
A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.
The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, the subsequent treatment appears to be related to the operational context of the procedure.
There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Event Description
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It was reported in a general comment that the physicians are not satisfied with the performance of the xience skypoint and the radial force is not strong enough needing to perform additional post dilatation at higher pressures.
There was no adverse patient sequela and there was no clinically significant delay in the procedure.
No additional information was provided.
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Search Alerts/Recalls
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