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

Model Number FDS40020

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

Patient Problems Stroke/CVA (1770); Paresis (1998)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that during a clinical trial, the subject flow diverter was used for treatment.A balloon was also used for in stent balloon angioplasty in a small area of non-apposition of the proximal end of the subject flow diverter.Excellent apposition was achieved and the procedure was completed successfully.Post procedure, the patient had a stroke that presented as right hemiparesis.Imaging done showed development of an ill defined acute to early sub acute infarct centered along the posterior limb left internal capsule.Patient was then started on integrillin infusion, taken to icu and phenylephrine was then initiated.Patient was in icu for approximately 5 days.In the physician's opinion, the event had a causal relationship to dual antiplatelet therapy, subject device, other stryker device and underlying condition or disease.Event was reported as recovering/resolving.No other information is available.

Event Description

It was reported that during a clinical trial, the subject flow diverter was used for treatment.A balloon was also used for in stent balloon angioplasty in a small area of non-apposition of the proximal end of the subject flow diverter.Excellent apposition was achieved and the procedure was completed successfully.Post procedure, the patient had a stroke that presented as right hemiparesis.Imaging done showed development of an ill defined acute to early sub acute infarct centered along the posterior limb left internal capsule.Patient was then started on integrillin infusion, taken to icu and phenylephrine was then initiated.Patient was in icu for approximately 5 days.In the physician's opinion, the event had a causal relationship to dual antiplatelet therapy, subject device, other stryker device and underlying condition or disease.Event was reported as recovering/resolving.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.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.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.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - 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: 12669709
• MDR Text Key: 277662386
• Report Number: 3008881809-2021-00443
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 22330524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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
• Treatment: TRANSFORM BALLOON (STRYKER); TRANSFORM BALLOON (STRYKER)
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White