MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS40015

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

Based on additional information received on 18 feb 2022, it was reported that friction was noted when the physician attempted to re-capture the subject diverting stent into the microcatheter.Therefore, this event meets the requirements of a reportable event with an awareness date of (b)(6) 2022(vn).

Manufacturer Narrative

The subject device is not yet returned.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection, as well as a functional evaluation, could not be performed.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 stent did not fully open and was removed without complication.It is probable that the reported 'very tortuous' anatomy contributed to the reported event, but as the device was not returned for analysis this cannot be conclusively confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

Event Description

Based on additional information received on 18 feb 2022, it was reported that friction was noted when the physician attempted to re-capture the subject diverting stent into the microcatheter.Therefore, this event meets the requirements of a reportable event with an awareness date of 18-feb-2022(vn).

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - 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: 13756125
• MDR Text Key: 288692094
• Report Number: 3008881809-2022-00115
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22846865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: AXS CATALYST 5 GUIDE CATHETER (STRYKER); EXCELSIOR XT27 MICROCATHETER (STRYKER); FLEXOR SHUTTLE GUIDING SHEATH (COOK MEDICAL)
• Patient Age: 61 YR
• Patient Sex: Female