MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD40017

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

Patient Problems Stroke/CVA (1770); Seizures (2063); Thrombosis (2100)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that the patient underwent an aneurysm procedure for partially thrombosed internal carotid artery (ica) on (b)(6) 2020 as an urgent elective case due to visual symptoms.The physician successfully completed the procedure with the subject stent.One week after the procedure, the patient had a seizure and following magnetic resonance imaging (mri) scan, a stroke related to in-stent thrombosis was confirmed inside the patient¿s anatomy.The patient is undergoing through occupational therapy and the physician is hopeful that the patient will recover and will remain independent.No further information is available.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Additional information indicates the device performed as intended.It is most likely that anatomical or procedural factors contributed to the reported event.As the device was not returned it cannot be definitively determined what caused the patient stroke, thrombosis and neurological deficit, an assignable cause of undeterminable will be assigned to the reported events.

Event Description

It was reported that the patient underwent an aneurysm procedure for partially thrombosed internal carotid artery (ica) on (b)(6)2020 as an urgent elective case due to visual symptoms.The physician successfully completed the procedure with the subject stent.One week after the procedure, the patient had a seizure and following magnetic resonance imaging(mri) scan, a stroke related to in-stent thrombosis was confirmed inside the patient¿s anatomy.The patient is undergoing through occupational therapy and the physician is hopeful that the patient will recover and will remain independent.No further information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10049140
• MDR Text Key: 190688673
• Report Number: 3008881809-2020-00145
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Catalogue Number: FD40017
• Device Lot Number: 21723074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (UNKNOWN MANUFACTURE); CATHETER (UNKNOWN MANUFACTURE); BALLOON CATHETER (UNKNOWN MANUFACTURE); CATHETER (UNKNOWN MANUFACTURE)
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 65 YR