MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a thrombectomy in the basilar was performed and subject retriever was used for procedure.Patient mrs (modified rankin scale) score before onset was noted to be 3 and aspects (alberta stroke program early ct score) was 10.After the first pass performed with subject device, mtici (modified treatment in cerebral ischemia) increased from 0 to 2b temporarily but final mtici returned to 0.Vessel dissection and vessel perforation occurred during procedure.Vessel dissection was allegedly related to the subject stent retriever, whereas vessel perforation was not related to the subject stent retriever.There was no device malfunction reported during procedure.7 days post procedure, mrs was 6 and the patient passed away due to subarachnoid hemorrhage (sah) which had developed before the procedure and caused basilar infarction.In the physician¿s opinion, the patient¿s death was caused by worsening of the disease (cerebral infarction).
Additional Manufacturer Narrative
Information received on 19-jan-2021 clarified that subject device was not used for procedure.Since there was no reported malfunction of the device that could have caused or contributed to the reported event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with the new awareness date of on 19-jan-2021.In addition, the device did not cause or contribute to any adverse event.Nor was it related to a malfunction or deterioration in the characteristics or performance of the device or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that a thrombectomy in the basilar was performed and subject retriever was used for procedure.Patient mrs (modified rankin scale) score before onset was noted to be 3 and aspects (alberta stroke program early ct score) was 10.After the first pass performed with subject device, mtici (modified treatment in cerebral ischemia) increased from 0 to 2b temporarily but final mtici returned to 0.Vessel dissection and vessel perforation occurred during procedure.Vessel dissection was allegedly related to the subject stent retriever, whereas vessel perforation was not related to the subject stent retriever.There was no device malfunction reported during procedure.7 days post procedure, mrs was 6 and the patient passed away due to subarachnoid hemorrhage (sah) which had developed before the procedure and caused basilar infarction.In the physician¿s opinion, the patient¿s death was caused by worsening of the disease (cerebral infarction).Update information: additional information provided on 19-jan-2021 clarified, that the subject stent was not used during the procedure.There was no reported malfunction of the device that could have caused or contributed to the reported event.

• Brand Name: TREVO XP PROVUE 4MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 11060733
• Report Number: 3012931345-2020-00224
• Device Sequence Number: 16863080
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR