MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject coil was implanted and herniated out or the aneurysm position.Therefore, the stent was used to recover the coil herniated and completed the procedure.The patient was discharged post procedure day 1.The patient is currently doing well without clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Additional Manufacturer Narrative
Section d4: expiration date: added.Section h4: manufacturing date: added.Section d gtin: corrected from (b)(4).Due to the automated manufacturing execution system (mes) 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.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.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 and the device was not returned, an assignable cause of undeterminable was assigned.
Event or Problem Description
It was reported that the subject coil was implanted and herniated out or the aneurysm position.Therefore, the stent was used to recover the coil herniated and completed the procedure.The patient was discharged post procedure day 1.The patient is currently doing well without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) 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.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.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 and the device was not returned, an assignable cause of undeterminable was assigned.
Event or Problem Description
It was reported that the subject coil was implanted and herniated out or the aneurysm position.Therefore, the stent was used to recover the coil herniated and completed the procedure.The patient was discharged post procedure day 1.The patient is currently doing well without clinical consequences to the patient.Update additional information: the mdr reports (initial /supplemental #1- mfr report # 3008881809-2023-00102 ) were originally submitted as the target coil was herniated outside the aneurysm neck and the stent was used to recover the coils herniated.Received additional information on 24-may-2024 confirmed that the reported event involved to the study citadel coil.Based on the physician¿s opinion, the citadel coil is usually supposed to keep the coil (target) in, but some cases where it doesn't.There was no device deficiency to the study citadel device.The study citadel device is currently not approved nor is it commercially sold in the usa; therefore, this citadel coil complaint is not subject to mdr reporting regulation.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: 6-june-2023.Further reviewing the additional information received on 24-may-2023 as the target coil was herniated and the stent was used to recover the coils herniated, therefore, the complaint pr # (b)(4) for target xl 360 soft 5mm x 15cm is still deemed reportable and the reportability assessment decision remains unchanged.
Event or Problem Description
It was reported that the subject coil was implanted and herniated out or the aneurysm position.Therefore, the stent was used to recover the coil herniated and completed the procedure.The patient was discharged post procedure day 1.The patient is currently doing well without clinical consequences to the patient.Update additional information: the mdr reports (initial /supplemental #1- mfr report # 3008881809-2023-00102 ) were originally submitted as the target coil was herniated outside the aneurysm neck and the stent was used to recover the coils herniated.Received additional information on 24-may-2024 confirmed that the reported event involved to the study citadel coil.Based on the physician¿s opinion, the citadel coil is usually supposed to keep the coil (target) in, but some cases where it doesn't.There was no device deficiency to the study citadel device.The study citadel device is currently not approved nor is it commercially sold in the usa; therefore, this citadel coil complaint is not subject to mdr reporting regulation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no adverse event and product problem b2 outcomes attributed to ae - corrected- no ' required intervention to prevent permanent impairment/damage (devices)' b5 executive summary -updated.D1 target xl 360 soft 5mm x 15cm/ catalog #/ lot# - corrected - no target involved to the reported event.H1 type of reportable event - corrected - no serious injury.The mdr reports (initial /supplemental #1- mfr report # 3008881809-2023-00102 ) were originally submitted as the target coil was herniated outside the aneurysm neck and the stent was used to recover the coils herniated.Received additional information on 24-may-2024 confirmed that the reported event involved to the study citadel coil.Based on the physician¿s opinion, the citadel coil is usually supposed to keep the coil (target) in, but some cases where it doesn't.There was no device deficiency to the study citadel device.The study citadel device is currently not approved nor is it commercially sold in the usa; therefore, this citadel coil complaint is not subject to mdr reporting regulation.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 the subject coil was implanted and herniated out or the aneurysm position.Therefore, the stent was used to recover the coil herniated and completed the procedure.The patient was discharged post procedure day 1.The patient is currently doing well without clinical consequences to the patient.Update additional information: the mdr reports (initial /supplemental #1- mfr report # 3008881809-2023-00102 ) were originally submitted as the target coil was herniated outside the aneurysm neck and the stent was used to recover the coils herniated.Received additional information on 24-may-2024 confirmed that the reported event involved to the study citadel coil.Based on the physician¿s opinion, the citadel coil is usually supposed to keep the coil (target) in, but some cases where it doesn't.There was no device deficiency to the study citadel device.The study citadel device is currently not approved nor is it commercially sold in the usa; therefore, this citadel coil complaint is not subject to mdr reporting regulation.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: 6-june-2023.Further reviewing the additional information received on 24-may-2023 as the target coil was herniated and the stent was used to recover the coils herniated, therefore, the complaint (b)(4) for target xl 360 soft 5mm x 15cm is still deemed reportable and the reportability assessment decision remains unchanged.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - adverse event and product problem.B2 outcomes attributed to ae - corrected- required intervention to prevent permanent impairment/damage (devices)'.B5 executive summary -updated - further reviewing the additional information received on 24-may-2023 as the target coil was herniated and the stent was used to recover the coils herniated, therefore, the complaint (b)(4) for target xl 360 soft 5mm x 15cm is still deemed reportable and the reportability assessment decision remains unchanged.D1 target xl 360 soft 5mm x 15cm/ catalog #/ lot#23794193 - corrected -target was involved to the reported event.Due to the automated manufacturing execution system (mes) 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.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.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 and the device was not returned, an assignable cause of undeterminable was assigned.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• Common Device Name: 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: 16469324
• Report Number: 3008881809-2023-00102
• Device Sequence Number: 15387975
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 07/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 23794193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 05/24/2023; 05/24/2023; 07/06/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/13/2023; 05/26/2023; 06/07/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: 1018 MICROCATHETER (STRYKER); GUIDE CATHETER (UNKNOWN MANUFACTURER); GUIDE SHEATH (UNKNOWN MANUFACTURER); GUIDEWIRE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White