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

Catalog Number FD32525

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that va dissecting of aneurysm was performed with two flow diverters.Initial flow diverter was deployed at distal of the lesion and did not cover the lesion completely.Physician proceeded to use subject flow diverter to cover the remainder of the lesion.The procedure was completed successfully, and patient was discharged the following day.Two days post operation, patient was hospitalized due to total occlusion of lesions.Patient is reported not to have taken prescribed medication when occlusion occurred.Patient had first thrombectomy performed.Four days post operation, the lesions blocked again.A second thrombectomy was done and patient condition is reported as stable.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.Additional information provided by the customer indicated that the first device did not perform as intended as the stent was deployed at distal of the lesion so the lesion was not all covered but when this subject stent was deployed at the lesion, the procedure was completed.There was no surgical delay in relation to the device used for the procedure, the patient¿s anatomy was normal lt, va.In the physician¿s opinion, the blockage of the lesions (total occlusion) 2 days post operation was not related to the subject device.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vessel thrombosis¿ 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 labelling and/or risk documentation files.

Event Description

It was reported that va dissecting of aneurysm was performed with two flow diverters.Initial flow diverter was deployed at distal of the lesion and did not cover the lesion completely.Physician proceeded to use subject flow diverter to cover the remainder of the lesion.The procedure was completed successfully, and patient was discharged the following day.Two days post operation, patient was hospitalized due to total occlusion of lesions.Patient is reported not to have taken prescribed medication when occlusion occurred.Patient had first thrombectomy performed.Four days post operation, the lesions blocked again.A second thrombectomy was done and patient condition is reported as stable.No other information is available.

• Brand Name: SURPASS EVOLVE 3.25MM X 25MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10932466
• MDR Text Key: 219122617
• Report Number: 3008881809-2020-00371
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: FD32525
• Device Lot Number: 22312213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SURPASS EVOLVE 3.25MM X 20MM (STRYKER); SURPASS EVOLVE 3.25MM X 20MM (STRYKER)
• Patient Outcome(s): Other; Required Intervention