MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.5MM X 20MM - HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0350200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure of stenotic mca (middle cerebral artery) with 80% stenosis and calcification at the lesion, after advancement of the stent delivery system (subject device)through tortuous anatomy to the lesion, while the stent delivery system was attempting to unsheath the stent during deployment the hypotube (stent stabilizer) snapped off at the hub of microcatheter outside the patient vasculature.With the stabilizer unable to deploy the stent, the system was removed from the guide catheter without any issues.According to physician vessel tortuosity of intended area of treatment may have contributed to the reported event.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available.Therefore, functional testing as well as physical analysis cannot 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.As per the available information, the dfu was followed during the preparation of the device, and the anatomy was very tortuous.It is most likely that procedural factors encountered during the preparation of the device contributed to the reported event, but as the device was not returned for evaluation this cannot be conclusively determined.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable will be assigned to the reported complaint.
Event or Problem Description
It was reported that during the procedure of stenotic mca (middle cerebral artery) with 80% stenosis and calcification at the lesion, after advancement of the stent delivery system (subject device)through tortuous anatomy to the lesion, while the stent delivery system was attempting to unsheath the stent during deployment the hypotube (stent stabilizer) snapped off at the hub of microcatheter outside the patient vasculature.With the stabilizer unable to deploy the stent, the system was removed from the guide catheter without any issues.According to physician vessel tortuosity of intended area of treatment may have contributed to the reported event.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: WINGSPAN 3.5MM X 20MM - HDE
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10901832
• Report Number: 3008881809-2020-00366
• Device Sequence Number: 1336388
• Product Code: NJE
• UDI-Device Identifier: 04546540722843
• UDI-Public: 04546540722843
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• 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): 02/02/2021

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: 11/30/2020
• Device Model Number: M003WS0350200
• Device Catalogue Number: M003WS0350200
• Device Lot Number: 20127721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR