MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036182050

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that the procedure was completed successfully and the 4 coils (subject device) were implanted.Post procedure, the patient suffered severe headache & increasing compression symptoms (abducens nerve).Three week cortisone therapy was prescribed to cure the adverse event and the adverse event of headache was resolved in 5 days.

Manufacturer Narrative

This is 3 of 4 mdrs.Device remains implanted inside the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date ¿ added.Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis.Therefore, the visual and functional inspection was not 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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this event of patient headache serious.

Event Description

It was reported that the procedure was completed successfully and the 4 coils (subject device) were implanted.Post procedure, the patient suffered severe headache & increasing compression symptoms (abducens nerve).Three week cortisone therapy was prescribed to cure the adverse event and the adverse event of headache was resolved in 5 days.

Manufacturer Narrative

This is 3 of 5 reports (3rd mdr).Section b1 adverse event/product problem - corrected - no adverse event section b2 outcomes attributed to ae - corrected - no serious injury, no medical intervention.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.There was no allegation of failure or malfunction against this device, therefore a risk analysis could not be performed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.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 Description

It was reported that the procedure was completed successfully and the 4 coils (subject device) were implanted.Post procedure, the patient suffered severe headache & increasing compression symptoms (abducens nerve).Three week cortisone therapy was prescribed to cure the adverse event and the adverse event of headache was resolved in 5 days.Update: additional information received on 24-mar-2023 stated that the reported event that the patient had severe headache after the procedure is not related to the coil.There was no clinical consequence to the patient reported as a result of this event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Manufacturer Narrative

This is 3 of 5 mdrs.B1: adverse event/product problem - corrected - adverse event.B2: outcomes attributed to ae - corrected - other serious (important medical events), and required intervention to prevent permanent impairment/damage (devices).B5: executive summary - updated.F10: / h6: clinical signs code grid - health effect - clinical code - updated.F10: / h6: health impact code grid - health effect - impact code - updated.F10: / h6: medical device problem code - device code grid - updated.H6: investigation conclusions - conclusion code grid - updated.H1: type of reportable event - corrected - serious injury.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

Event Description

It was reported that the procedure was completed successfully and the 4 coils (subject device) were implanted.Post procedure, the patient suffered severe headache & increasing compression symptoms (abducens nerve).Three week cortisone therapy was prescribed to cure the adverse event and the adverse event of headache was resolved in 5 days.Update: additional information received on 24-mar-2023, stated that the reported event that the patient had severe headache after the procedure is not related to the coil.There was no clinical consequence to the patient reported as a result of this event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.Update: additional information received on 12-jun-2023, stated that the reported event that the patient had severe headache after the procedure is related to the subject coil.

Manufacturer Narrative

This is 3 of 5 reports (3rd mdr) section b1 adverse event/product problem - corrected - no adverse event.Section b2 outcomes attributed to ae - corrected - no other serious (important medical events), no required intervention to prevent permanent impairment/damage (devices), section h1 type of reportable event - corrected - no serious injury.B5 executive summary - updated.F10 / h6 clinical signs code grid - health effect - clinical code - updated.F10 / h6 health impact code grid - health effect - impact code - updated.F10 / h6 medical device problem code - device code grid - updated.H6 conclusion code grid ¿ updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.A labelling review and risk review could not be performed as the device problem is unknown/unclear.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.As the device problem was unknown/unclear from the information received and the device was not returned for analysis, an assignable cause of undeterminable will be assigned to this complaint.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 Description

It was reported that the procedure was completed successfully and the 4 coils (subject device) were implanted.Post procedure, the patient suffered severe headache & increasing compression symptoms (abducens nerve).Three week cortisone therapy was prescribed to cure the adverse event and the adverse event of headache was resolved in 5 days.Update: additional information received on 24-mar-2023 stated that the reported event that the patient had severe headache after the procedure is not related to the coil.There was no clinical consequence to the patient reported as a result of this event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.Update: additional information received on 12-jun-2023 stated that the reported event that the patient had severe headache after the procedure is related to the subject coil.Update: updated information was received after cec (clinical events committee) adjudication on 05-jul-2023 stated that the reported event that the patient had severe headache after the procedure is not related to the subject coil.

• Brand Name: TARGET XXL 360 20MM X 50CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 14109859
• MDR Text Key: 289257155
• Report Number: 3008881809-2022-00176
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128345
• UDI-Public: 07613327128345
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2024
• Device Model Number: M0036182050
• Device Catalogue Number: M0036182050
• Device Lot Number: 22915273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 03/24/2023; 06/12/2023; 07/05/2023
• Supplement Dates FDA Received: 05/27/2022; 04/04/2023; 06/26/2023; 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); SURPASS EVOLVE FLOW DIVERTER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Outcome(s): Other; Required Intervention