MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003111FPP0

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Premature Activation (1484)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/ microscopic inspection: the stent was noted to be partially deployed.The stent was noted to be deformed when fully deployed.The stent delivery catheter was noted to be damaged.The stent delivery catheter was noted to be leaking.The pusher wire was noted to be kinked/bent.The distal pusher wire was noted to be broken.The stent delivery catheter shaft was inspected and severe damage was noted to the entire catheter shaft.Functional inspection: the surpass streamline stent was advanced through the catheter shaft, the stent was deployed.Friction was noted.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 was confirmed based on the analysis of the returned device.The analysis results are consistent with the reported event.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.As per the additional information, the device was prepared as per the dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was severely tortuous.The device was returned and the stent, delivery catheter and stent stabilizer was noted to be damaged/deformed which is indicative of the reported event.It is probable that the device experienced difficulty during stent deployment due to the extreme tortuous anatomy causing the entire device and delivery system to become damaged/deformed.An assignable cause of procedural factors will be assigned to the reported stent delivery catheter/guide catheter friction, stent delivery catheter kinked/bent and stent delivery catheter friction and to the analyzed stent partial deployment, stent deformed, stent delivery catheter deformed, catheter shaft leak during use, stent delivery catheter/guide catheter friction, stent delivery catheter kinked/bent stent stabilizer kinked/bent and stent stabilizer broken/fractured 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 Description

The subject flow diverter was returned for analysis and the device investigation revealed that stent was partially deployed, catheter shaft was leak during use and stent stabilizer was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SURPASS STREAMLINE 4.0MM X 25MM - CE
• 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: 14190307
• MDR Text Key: 295426285
• Report Number: 3008881809-2022-00191
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Catalogue Number: M003111FPP0
• Device Lot Number: 22422485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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: 6F LONG SHEATH (COOK MEDICAL); CATALYST 5 (DISTAL ACCESS CATHETER) STRYKER; X-27 MICROCATHETER (STRYKER)
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 66 KG