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

Catalog Number FD40020

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2020

Event Type  malfunction  

Manufacturer Narrative

The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.The subject device is unavailable to manufacturer.

Event Description

It was reported that the stent (subject device) attempted to be deployed below posterior communicating artery (pcom) aneurysm with the distal artery measured around 3.6mm and proximal around 4.1mm, the distal end of the stent (subject device) did not open completely even after deploying 25%.After re sheathing the subject device, it did open at the bent after several maneuvering and resheathing attempts.The stent (subject device) was finally taken out along with microcatheter and the stent (subject device) was deployed completely inside saline bowl which half of the stent (subject device) was opened and another half was compressed completely.Finally, the physician replaced it with a new atlas stent and completed the procedure without clinical consequences to the patient.The physician plans to put a braided stent inside the new alas stent after few weeks.

Manufacturer Narrative

B1: adverse event/product problem: not applicable h1: type of reportable event: not applicable 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 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.No anomalies were noted to the device prior to the procedure and the dfu was followed during the preparation of the device.As per the event description, 'physician started to unsheath evolve below pcom but the distal end did not open completely even after deploying 25%.After resheathing the device, it did open at the bent after several maneuvering and resheathing attempts.'.As the device was not returned to site for analysis, an assignable cause of 'undeterminable' will be assigned to the reported defects.Non-reportable rationale: based on further review, the reported event description, the subject flow diverter failed to open but was recaptured by the operator and successfully removed from the patient¿s body.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.

Event Description

It was reported that the stent (subject device) attempted to be deployed below posterior communicating artery (pcom) aneurysm with the distal artery measured around 3.6mm and proximal around 4.1mm, the distal end of the stent (subject device) did not open completely even after deploying (b)(4).After re sheathing the subject device, it did open at the bent after several maneuvering and resheathing attempts.The stent (subject device) was finally taken out along with microcatheter and the stent (subject device) was deployed completely inside saline bowl which half of the stent (subject device) was opened and another half was compressed completely.Finally, the physician replaced it with a new atlas stent and completed the procedure without clinical consequences to the patient.The physician plans to put a braided stent inside the new alas stent after few weeks.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - 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: 9665344
• MDR Text Key: 177842340
• Report Number: 3008881809-2020-00029
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Catalogue Number: FD40020
• Device Lot Number: 21723075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT 27 MICROCATHETER (STRYKER); NEURON 053 (NON STRYKER); NEURON MAX (NON STRYKER)
• Patient Age: 32 YR