STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER
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Model Number 90185 |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)
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Event Date 06/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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During the procedure for thromectomy for right m1 distal was performed on (b)(6) 2020.Prior to procedure patient modified rankin scale (mrs) before onset was 0, thrombolysis in cerebral infarction (tici) score was 0 and nih stroke scale (nihss) was 20.After one pass was preformed final tici score was 2b and post procedure nihss was 12.The physician did not realize the vessel perforation and dissection at the time of finishing the procedure.Intracerebral hemorrhage (ich) type ph1 was observed in ct and mri follow-up after the procedure on (b)(6), then protamine and transamin was administered to the patient and hemostasis was observed.It was noted that vessel perforation and vessel dissection was in relation to the difficult removal of the subject retriever during the procedure.On (b)(6), patient mrs was 4 at time of discharge.
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Event Description
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During the procedure for thromectomy for right m1 distal was performed on (b)(6) 2020.Prior to procedure patient modified rankin scale (mrs) before onset was 0, thrombolysis in cerebral infarction (tici) score was 0 and nih stroke scale (nihss) was 20.After one pass was preformed final tici score was 2b and post procedure nihss was 12.The physician did not realize the vessel perforation and dissection at the time of finishing the procedure.Intracerebral hemorrhage (ich) type ph1 was observed in ct and mri follow-up after the procedure on june 17th, then protamine and transamin was administered to the patient and hemostasis was observed.It was noted that vessel perforation and vessel dissection was in relation to the difficult removal of the subject retriever during the procedure.On july 27th, patient mrs was 4 at time of discharge.
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Manufacturer Narrative
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Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Information indicates the anatomy was severely tortuous.It is most likely that anatomical factors encountered during the procedure contributed to the reported event.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undetermined will be assigned to the difficult/unable to withdraw retriever.The reported patient vessel perforation, 'patient vessel dissection' and patient intracranial hemorrhage is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to these reported defects.
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