MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDS32525

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

Patient Problems Memory Loss/Impairment (1958); Loss of Vision (2139); Dysphasia (2195); Shaking/Tremors (2515); Taste Disorder (4422); Epistaxis (4458); Partial Hearing Loss (4472); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  Injury  

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 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.It was reported that the patient 'believes that she has an allergy to the implanted device'.Due to a lack of information on the event, and while there are a number of potential causes for the reported issue, analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to this complaint.The dfu states the following warning: persons allergic to nickel, cobalt chromium or platinum tungsten metal may suffer an allergic response to this system.The device is not available to the manufacturer, as device is implanted in patient.

Event Description

It was reported that neuro endovascular flow diverter implantation procedure was performed on female patient.Patient believes that she has an allergy to the implanted device.Patient is consulting the physician for post-operative follow up regarding allergies and side effects.Flow diverter implantation was performed by a different physician at a different facility, details related to the procedure were unknown.Physician ran lab work which indicated 2.0 chromium levels in urine and also high levels of arsenic was noted.Patient was having them re-tested by a rheumatologist.No other information is available.

Event Description

It was reported that neuro endovascular flow diverter implantation procedure was performed on female patient.Patient believes that she has an allergy to the implanted device.Patient is consulting the physician for post-operative follow up regarding allergies and side effects.Flow diverter implantation was performed by a different physician at a different facility, details related to the procedure were unknown.Physician ran lab work which indicated 2.0 chromium levels in urine and also high levels of arsenic was noted.Patient was having them re-tested by a rheumatologist.No other information is available.

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.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.It was reported that the patient 'believes that she has an allergy to the implanted device.Due to a lack of information on the event, and while there are a number of potential causes for the reported issue of patient allergic reaction, patient complications, patient neurological deficit and patient hemorrhage, blood loss without sequelae, analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to this complaint.The dfu states the following warning: persons allergic to nickel, cobalt chromium or platinum tungsten metal may suffer an allergic response to this system.

• Brand Name: SURPASS EVOLVE 3.25MM X 25MM - 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: 13944695
• MDR Text Key: 288693093
• Report Number: 3008881809-2022-00144
• 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: 04/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Catalogue Number: FDS32525
• Device Lot Number: 22240714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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 Sex: Female