MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 2 of 3 mdrs.The device is not available to the manufacturer.
Event or Problem Description
It was reported that one month post procedure, patient came with stroke symptoms and mri confirmed micro-bleeds in the brain.Patient was hospitalized and needed medication to return to baseline.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis, therefore visual inspection and functional testing was not performed.The risk of the reported event is covered in the device directions for use (dfu).The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Information received indicated the patient came in with stroke symptoms one month after the procedure was done.Mri performed that demonstrated 60 or 70 small bleeds in their brain.Also additional information received indicated that the devices performed as intended.The device was not returned.An assignable cause of anticipated procedural complication will be assigned to the reported event of patient hemorrhage, blood loss with sequelae and patient stroke.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that one month post procedure, patient came with stroke symptoms and mri confirmed micro-bleeds in the brain.Patient was hospitalized and needed medication to return to baseline.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14038136
• Report Number: 3008881809-2022-00158
• Device Sequence Number: 4558660
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113778
• 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): 06/16/2022

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 Expiration Date: 09/27/2024
• Device Model Number: M003XT2750810
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 23196310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SURPASS EVOLVE FLOW DIVERTER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown