MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 135CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2735810
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
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 during the procedure, while retreatment of recanalization/residual for a previously treated aneurysm friction was felt while advancing the stent inside the subject microcatheter but the stent was deployed and the distal tip of the subject microcatheter was also damaged.The patient suffered subarachnoid bleeding and lenticulostriate artery perforation which was alleged to be caused by the subject microcatheter.There was no treatment performed to resolved the adverse event.No additional information available.
Additional Manufacturer Narrative
B1 - adverse event - corrected - no adverse event.H1 serious injury - corrected - no serious injury.Additional information received clarified the the adverse event was not related to the subject microcatheter.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 during the procedure, while retreatment of recanalization/residual for a previously treated aneurysm friction was felt while advancing the stent inside the subject microcatheter but the stent was deployed and the distal tip of the subject microcatheter was also damaged.The patient suffered subarachnoid bleeding and lenticulostrial artery perforation which was alleged to be caused by the subject microcatheter.There was no treatment performed to resolved the adverse event.No additional information available.Additional information received on 20-apr-2022 clarified that the subarachnoid bleeding and artery perforation was not related to the subject microcatheter.
Additional Manufacturer Narrative
B1 - adverse event - corrected - adverse event.B2 outcomes attributed to ae - updated.B5 executive summary - updated.F10 / h6 health effect - clinical code - updated.F10 / h6 health effect - impact code - updated.F10 / h6 medical device problem code - updated.H6.Investigation conclusions - updated.H1 type of reportable event - no serious injury - corrected - serious injury.D4 expiration date- updated.H4 manufacturing date- updated.
Event or Problem Description
It was reported that during the procedure, while retreatment of recanalization/residual for a previously treated aneurysm friction was felt while advancing the stent inside the subject microcatheter but the stent was deployed and the distal tip of the subject microcatheter was also damaged.The patient suffered subarachnoid bleeding and lenticulostrial artery perforation which was alleged to be caused by the subject microcatheter.There was no treatment performed to resolved the adverse event.No additional information available.Additional information received on 20-apr-2022 clarified that the subarachnoid bleeding and artery perforation was not related to the subject microcatheter.Additional information received on 20-sep-2022 clarified that the subarachnoid bleeding and artery perforation was related to the subject microcatheter and not to the study device.
Event or Problem Description
It was reported that during the procedure, while retreatment of recanalization/residual for a previously treated aneurysm friction was felt while advancing the stent inside the subject microcatheter but the stent was deployed and the distal tip of the subject microcatheter was also damaged.The patient suffered subarachnoid bleeding and lenticulostrial artery perforation which was alleged to be caused by the subject microcatheter.There was no treatment performed to resolved the adverse event.No additional information available.Additional information received on 20-apr-2022 clarified that the subarachnoid bleeding and artery perforation was not related to the subject microcatheter.Additional information received on 20-sep-2022 clarified that the subarachnoid bleeding and artery perforation was related to the subject microcatheter and not to the study device.
Additional Manufacturer Narrative
This 1 out of 2 mdrs (1st mdr).Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.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.Additional information was provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was maintained throughout the clinical procedure.Also there was a surgical delay of 5 mins.Also additional information indicated the distal of the coil delivery wire hit a small lentoculostriate artery when massaging the stent causing lenticulostrial artery perforation.An assignable cause of use error will be assigned to patient vessel perforation and patient intracranial hemorrhage as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.The distal of the coil delivery wire hit a small lentoculostriate artery when massaging the stent causing lenticulostrial artery perforation.
Event or Problem Description
It was reported that during the procedure, while retreatment of recanalization/residual for a previously treated aneurysm friction was felt while advancing the stent inside the subject microcatheter but the stent was deployed and the distal tip of the subject microcatheter was also damaged.The patient suffered subarachnoid bleeding and lenticulostrial artery perforation which was alleged to be caused by the subject microcatheter.There was no treatment performed to resolved the adverse event.No additional information available.Additional information received on 20-apr-2022 clarified that the subarachnoid bleeding and artery perforation was not related to the subject microcatheter.Additional information received on 20-sep-2022 clarified that the subarachnoid bleeding and artery perforation was related to the subject microcatheter and not to the study device.Update: received additional information on 26-apr-2023 stated that according to cec adjudication the subarachnoid bleeding and artery perforation had a possible relationship with the study device.This complication was supported by a short occlusion with a balloon.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 135CM
• 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: 14147658
• Report Number: 3008881809-2022-00184
• Device Sequence Number: 19569127
• Product Code: DQY
• UDI-Device Identifier: 04546540698094
• UDI-Public: 04546540698094
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/03/2023

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: 02/01/2023
• Device Model Number: M003XT2735810
• Device Catalogue Number: M003XT2735810
• Device Lot Number: 22113314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 09/20/2022; 10/31/2022; 04/26/2023
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 04/27/2022; 10/18/2022; 11/18/2022; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female