MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDS40012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

The subject device remained inside patient.

Event Description

It was reported that the patient with a previously ruptured right pcom (posterior communicating artery) region aneurysm.The aneurysm was previously coiled and it was approximately a 5mm aneurysm with a small recurrence was noted.Pru at the time the occlusion was observed was 236.The physician decided to treat with a subject 4.0x12mm surpass evolve.The date of the procedure was (b)(6) 2021.The procedure went smoothly, and the device performed as expected.The patient was discharged on dapt (dual antiplatelet therapy).On routine 6-month follow-up on (b)(6) 2021, the ica (internal carotid artery) appeared occluded at the level of the device.It was unknown what was the reason for the vessel occlusion.The patient¿s current condition is asymptomatic and functioning as normal.No other information was provided.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual testing as well as functional testing cannot be performed as the subject device is not available.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.It was reported that the patient was a 46 yo female with a previously ruptured right pcom region aneurysm.The aneurysm was previously coiled and on follow-up a recurrence was noted.The physician decided to treat with a 4.0x12mm surpass evolve.The date of the procedure was (b)(6) 2021.The procedure went smoothly.The patient was discharged on dapt.On routine 6-month follow-up on (b)(6) 2021, the ica appeared occluded at the level of the device.Patient was asymptomatic.Based upon medical review, the harm observed in the 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 with the directions for use, 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 patient with a previously ruptured right pcom (posterior communicating artery) region aneurysm.The aneurysm was previously coiled and it was approximately a 5mm aneurysm with a small recurrence was noted.Pru at the time the occlusion was observed was 236.The physician decided to treat with a subject 4.0x12mm surpass evolve.The date of the procedure was (b)(6) 2021.The procedure went smoothly, and the device performed as expected.The patient was discharged on dapt (dual antiplatelet therapy).On routine 6-month follow-up on (b)(6) 2021, the ica (internal carotid artery) appeared occluded at the level of the device.It was unknown what was the reason for the vessel occlusion.The patient¿s current condition is asymptomatic and functioning as normal.No other information was provided.

• Brand Name: SURPASS EVOLVE 4.0MM X 12MM - PMAS
• 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: 12514263
• MDR Text Key: 272746325
• Report Number: 3008881809-2021-00390
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FDS40012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female