MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Neurovascular flow diverter implantation was performed for aneurysmal treatment  in a (b)(6) yr.Old female patient with other relevant history of marfan's syndrome.During initial flow diverter implantation procedure the full expansion of stent cell with apposition to vessel wall achieved after implantation and confirmed under fluoroscopy.Though the physician did not have any complaints from the initial stent placement procedure and there was not a lot of stasis in either aneurysm but the physician decided to use non stryker balloon to post process to ensure good seal across  aneurysm neck.  during 5 week post procedure follow up imaging studies it was noticed that the vessel diameter distal to the aneurysm where the distal end of the subject flow diverter was placed had narrowed by approximately 50%.The physician is uncertain if her marfan syndrome contributes to the situation.The physician did not comment on the blood flow changes distal to the narrowing due to the reported issue.There was no neurological deficit or sequelae noticed due reported issue.No additional treatment is currently planned.The patient is scheduled for a routine 6-month follow-up. patient outcome is ongoing.No other information is available.
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 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 provided by the customer indicated that there were no anomalies noted to the device prior to use, the device was prepared as per the dfu.Continuous flush was maintained throughout the procedure.Other devices used in the procedure in conjunction with the subject device were catheter, microcatheter, guidewire, balloon catheter.The size of the stent was appropriate for treatment site.No patch testing was done preoperatively for hypersensitivity reaction.The medical procedure performed was neurovascular flow diverter implantation.The stent was recaptured/resheathed back during the procedure 3 times.Full expansion of stent cell with apposition to vessel wall was achieved after implantation and confirmed under fluoroscopy.The devices performed as intended.During follow up, the changes observed in the size or shape of the aneurysm during follow-up was that the aneurysm was gone.The scepter balloon dilatation was used at the stent implantation site inside the stent immediate after stent deployment, to ensure a good seal across both aneurysm necks because there was not a lot of stasis in either aneurysm.Referring to the information provided into the event details: ¿the vessel diameter distal to the aneurysm where the distal end of the evolve flow diverter was placed had narrowed by approximately 50%¿ refers to ¿narrowing of the vessel luminal diameter¿, besides the lumen narrowing, no additional changes were noted to the vessel wall, the physician did not comment on the amount of blood supply.He only expressed concern about the vessel narrowing.There was no neurological deficit or sequelae noticed due reported issue.The physician is not sure what was the reason for the event but as indicated in the initial description, the patient does have marfan syndrome.He is uncertain if her marfan syndrome contributed to the situation.The physician does not feel that the anatomy and/or location of intended area of treatment may have contributed to the reported event.There were no other difficulties encountered during the procedure (while transfer/advancement/deployment of the stent and withdrawal) that could have contributed to reported issue other than described in the initial description.The patient is scheduled for a routine 6 month follow-up.No additional treatment is currently planned to treat the reported issue.The patient is not on added medication or treatment due to the reported event.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 of patient parent vessel stenosis.
Event or Problem Description
Neurovascular flow diverter implantation was performed for aneurysmal treatment  in a 59m yr.Old female patient with other relevant history of marfan's syndrome.During initial flow diverter implantation procedure the full expansion of stent cell with apposition to vessel wall achieved after implantation and confirmed under fluoroscopy.Though the physician did not have any complaints from the initial stent placement procedure and there was not a lot of stasis in either aneurysm but the physician decided to use non stryker balloon to post process to ensure good seal across  aneurysm neck.  during 5 week post procedure follow up imaging studies it was noticed that the vessel diameter distal to the aneurysm where the distal end of the subject flow diverter was placed had narrowed by approximately 50%.The physician is uncertain if her marfan syndrome contributes to the situation.The physician did not comment on the blood flow changes distal to the narrowing due to the reported issue.There was no neurological deficit or sequelae noticed due reported issue.No additional treatment is currently planned.The patient is scheduled for a routine 6-month follow-up. patient outcome is ongoing.No other information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - PMAS
• Common Device Name: 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: 14108105
• Report Number: 3008881809-2022-00172
• Device Sequence Number: 15059878
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 04/07/2024
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 22846870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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: BENCHMARK ACCESS CATHETER (PENUMBRA); SCEPTER BALLOON CATHETER (MICROVENTION); XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female