MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  Injury  

Event Description

It was reported that the retreatment of recanalization/residual previously treated aneurysm in the left posterior communicating artery (pca) in a patient with hypertension, post deployment the physician passed the microcatheter inside the stent to make sure that the stent is nicely opened.While doing so, the delivery wire of the subject flow diverting stent perforated the lenticulostrial artery and there was a intracranial bleeding (subarachnoid bleeding).Physician used a balloon for the short occlusion for the reported adverse event.No additional information available.

Manufacturer Narrative

The device is not available to the manufacturer as the subject device was implanted inside the patient's vasculature.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 on the information provided in the complaint, there was no damage to the microcatheter and the problem is not related to the microcatheter.Damage was noticed at the end after opening the stent, during the massage of the stent to be sure that its well open, the massage was done with the microcatheter.The physician massaged the stent to pass inside the stent by the micro catheter after the complete delivery of the stent which is thought to be done by all physicians after using a flow diverter stent.The massaging was not done as an intervention to oppose the stent to the vessel wall as the stent was failed / unable to open it was just to be sure that the stent fully opened.There was no device defect, the bleeding occurred during the massage of the stent (with a large pressure secondary to the anatomy of the carotid artery), the distal part (coil) of the pusher punctures a small lenticulostrial artery, this complication was supported by a short occlusion with a balloon.In the case of this complaint, it is most probable the massaging of the stent resulted in the puncture to the artery and subsequent bleeding.Therefore, an assignable cause of procedural factors will be assigned to the as reported ¿patient vessel perforation¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of anticipated procedural complication will be assigned to the as reported ¿patient intracranial hemorrhage¿ 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 Description

It was reported that the retreatment of recanalization/residual previously treated aneurysm in the left posterior communicating artery (pca) in a patient with hypertension, post deployment the physician passed the microcatheter inside the stent to make sure that the stent is nicely opened.While doing so, the delivery wire of the subject flow diverting stent perforated the lenticulostrial artery and there was a intracranial bleeding (subarachnoid bleeding).Physician used a balloon for the short occlusion for the reported adverse event.No additional information available.

Event Description

It was reported that the retreatment of recanalization/residual previously treated aneurysm in the left posterior communicating artery (pca) in a patient with hypertension, post deployment the physician passed the microcatheter inside the stent to make sure that the stent is nicely opened.While doing so, the delivery wire of the subject flow diverting stent perforated the lenticulostrial artery and there was a intracranial bleeding (subarachnoid bleeding).Physician used a balloon for the short occlusion for the reported adverse event.No additional information available.Additional information received on 20-sep-2022 clarified that the subarachnoid bleeding and artery perforation was related to the microcatheter and not related to the subject flow diverting stent.

Manufacturer Narrative

B1 adverse event/product problem - corrected - no product problem/no adverse event.H1 serious injury - corrected - no serious injury.

Manufacturer Narrative

B1 adverse event/product problem - updated to adverse event.B2 outcomes attributed to ae - updated to 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 - updated to serious injury.Although the dhr (device history record) could not be reviewed because the lot number remains unknown, 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 on the information provided in the complaint, there was no damage to the microcatheter and the problem is not related to xt-27.Damage was noticed at the end after opening the stent, during the massage of the stent to be sure that its well open, the massage was done with the microcatheter after the complete delivery of the stent which is thought to be done by all physicians after using a flow diverter stent.The massaging was not done as an intervention to oppose the stent to the vessel wall as the stent was failed / unable to open, it was just to be sure that the stent fully opened.There was no device defect, the bleeding occurred during the massage of the stent (with a large pressure secondary to the anatomy of the carotid artery), the distal part (coil) of the pusher punctures a small lenticulostrial artery, this complication was supported by a short occlusion with a balloon.Additional information received on 20-sep-2022 regarding update to adverse event 1 ¿ intracranial bleeding; relationship to evolve device - not related (related to xt-27) and relationship to other stryker devices - probable.Dd#1- microcatheter, sae- yes additional information received on 06-apr-2023 stated the xt27 microcatheter does not allow recovery of the second stent.2 implanted surpass evolve devices overlapped.In the case of this complaint, it is most probable the massaging of the stent resulted in damage to the stent that punctured the artery and caused the subsequent bleeding.Therefore, an assignable cause of procedural factors will be assigned to the as reported ¿patient vessel perforation¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of anticipated procedural complication will be assigned to the as reported ¿patient intracranial hemorrhage¿ 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 Description

It was reported that the retreatment of recanalization/residual previously treated aneurysm in the left posterior communicating artery (pca) in a patient with hypertension, post deployment the physician passed the microcatheter inside the stent to make sure that the stent is nicely opened.While doing so, the delivery wire of the subject flow diverting stent perforated the lenticulostrial artery and there was a intracranial bleeding (subarachnoid bleeding).Physician used a balloon for the short occlusion for the reported adverse event.No additional information available.Additional information received on 20-sep-2022 clarified that the subarachnoid bleeding and artery perforation was related to the microcatheter and not related to the subject flow diverting stent.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.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 14417430
• MDR Text Key: 291845427
• Report Number: 3008881809-2022-00230
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170024/S003
• 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
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female