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
Event or Problem Description
It was reported that during a pcomm aneurysm case, the customer took the microcatheter and the stent (subject device) up into the m1.The physician was unable to re-sheath the stent (subject device).He relaxed the entire system, but was still not able to advance the microcatheter by advancing the microcatheter or pulling on the delivery wire.The intermediate catheter was located in the ica (cavernous segment), but was not able to track it up further.As the physician attempted to re-sheath, the stent (subject device) came off the re-sheath pad.The physician at this point removed the entire system by locking down the microcatheter on the delivery wire and removed the system.Upon visually inspecting the system after removal, the microcatheter looked stretched and ovalized.There were no clinical consequences reported to the patient due to this event.No further information available at this time.
Additional Manufacturer Narrative
This is 1 of 3 reports (1st mdr).The device is not available to the manufacturer.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 sdw (stent delivery wire) was found to be inside the xt-27 catheter, the sdw (stent delivery wire) was found to be kinked/bent, the stent (subject device) was found to be deployed and not returned.A functional test was unable to perform as the stent (subject device) was found to be deployed.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 customer took the xt27 and evolve stent up into the m1.Upon unsheathing the flow diverter, the physician was unable to re-sheath the device.He relaxed the entire system but was still not able to advance the xt27 catheter by advancing the xt27 catheter or pulling on the delivery wire.The cat (catalyst access catheter) was located in the ica (cavernous segment) but was not able to track it up further.As he attempted to re-sheath, the stent (subject device) came off the re-sheath pad.The physician at this point removed the entire system by locking down the xt27 catheter on the delivery wire and removed the system.Upon visually inspecting the system after removal, the xt27 catheter looked stretched and ovalized".The stent (subject device) and the introducer were not returned for analysis.Product analysis found the stent (subject device) had been deployed from the surpass evolve flow diverter system.This indicates the stent (subject device) had been deployed too far out of the microcatheter to allow the stent (subject device) 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 ¿sdw kinked/bent¿ and ¿stent deployed prematurely during use¿ 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, the customer took the microcatheter and the stent (subject device) up into the m1.The physician was unable to re-sheath the stent (subject device).He relaxed the entire system, but was still not able to advance the microcatheter by advancing the microcatheter or pulling on the delivery wire.The intermediate catheter was located in the ica (cavernous segment), but was not able to track it up further.As the physician attempted to re-sheath, the stent (subject device) came off the re-sheath pad.The physician at this point removed the entire system by locking down the microcatheter on the delivery wire and removed the system.Upon visually inspecting the system after removal, the microcatheter looked stretched and ovalized.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: 12872573
• Report Number: 3008881809-2021-00490
• Device Sequence Number: 6119948
• 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): 01/19/2022

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: 02/28/2024
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22748433
• 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: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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