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

Model Number	FDS40015
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 3 reports (2nd mdr).The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a pcomm aneurysm case, upon attempting to deploy and re-sheath the stent (subject device) , the physician lost the ability to re-sheath the system.He took the intermediate catheter all the way up into the m1, but the physician was still unable to re-sheath the stent (subject device).As the physician tried to re-sheath, the stent (subject device) jumped forward and was no longer on the re-sheath pad of the delivery wire.The stent (subject device) was trapped inside the microcatheter on the delivery wire, so the physician took the intermediate catheter up and was able to recapture the stent (subject device) inside the intermediate catheter.At this point, the evolve system was removed.Upon visually inspecting the system, the microcatheter looked stretched and damaged.There were no clinical consequences reported to the patient due to this event.No further information available at this time.
Additional 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.During visual inspection, the stent (subject device) returned together with other stents and catheters used in the procedure, the device was found to be inside the xt-27 catheter, the stent (subject device) was found to partially deployed from the distal end of the xt-27 catheter, the sdw (stent delivery wire) was found to be kinked/bent, and the stent (subject device) was found to be deformed (distal end) and (proximal end).A functional test for stent difficult/unable to advance or pullback through catheter ¿ fail.The stent (subject device) was advanced and deployed; however, friction was noted.A functional test for stent difficult/unable to pull stent back into sheath was unable to perform as the stent (subject device) was found to be partially deployed from the distal end of the catheter.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.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 event description stated "the intermediate catheter was switched to a sofia per the physicians request, but upon attempting to deploy and re-sheath the 2nd device, he again lost the ability to re-sheath the system.He took the intermediate catheter all the way up into the m1, but the physician said he was still unable to re-sheath the stent.As he tried to re-sheath, the stent jumped forward and the stent was no longer on the re-sheath pad of the delivery wire.The stent was trapped inside the xt27 on the delivery wire, so the physician took the sofia up and was able to recapture the stent inside the intermediate catheter.At this point, the 2nd evolve system was removed.Upon visually inspecting the system, the xt27 looked similar to the first deployment ¿ stretched and damaged".The introducer was not returned for analysis.Product analysis found the sdw (stent delivery wire) was damaged, and the stent (subject device) had been deployed from the surpass evolve flow diverter system and was deformed.This indicates the stent (subject device) had been deployed too far out of the microcatheter to allow the stent to be re-captured, i.E., the re-sheath marker had been advanced beyond the microcatheter marker band, which is effectively a full deployment and the re-sheath pad is no longer effective at this point, and re-capture is not possible.Three xt-27 microcatheters were returned.All xt-27 microcatheters were inspected and were found to be kinked/bent and stretched, indicating procedural or anatomical factors may have contributed to the reported event.An assignable cause of procedural factors will be assigned to the reported 'stent deployed prematurely during use', ¿stent difficult/unable to pull stent back into sheath' and ¿stent difficult/unable to advance or pullback through catheter¿ and to the analyzed defects ¿stent deployed prematurely during use¿, ¿stent difficult/unable to advance or pullback through catheter¿, ¿sdw kinked/bent¿, ¿stent deformed¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during a pcomm aneurysm case, upon attempting to deploy and re-sheath the stent (subject device) , the physician lost the ability to re-sheath the system.He took the intermediate catheter all the way up into the m1, but the physician was still unable to re-sheath the stent (subject device).As the physician tried to re-sheath, the stent (subject device) jumped forward and was no longer on the re-sheath pad of the delivery wire.The stent (subject device) was trapped inside the microcatheter on the delivery wire, so the physician took the intermediate catheter up and was able to recapture the stent (subject device) inside the intermediate catheter.At this point, the evolve system was removed.Upon visually inspecting the system, the microcatheter looked stretched and damaged.There were no clinical consequences reported to the patient due to this event.No further information available at this time.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - PMAS
• Common Device Name: 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: 12872626
• Report Number: 3008881809-2021-00491
• Device Sequence Number: 3707872
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 2294995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST 5 (STRYKER MANUFACTURER); EXCELSIOR XT-27 (STRYKER MANUFACTURER); SOFIA INTERMEDIATE CATHETER (NON- STRYKER DEVICE)
• Patient Sex: Unknown