MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E25150

Device Problems Break (1069); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the device found that the stent delivery wire (sdw) was kinked at 135cm from the proximal end and the distal end of the sdw was broken.The stent was returned in its deployed state.No other anomalies were noted.A full functional test was unable to be performed as the stent had been deployed, however, the sdw was able to be advanced and retracted through the sheath without difficulty.Information available also stated that the device was confirmed to be in good condition post unpacking and preparation and the device was prepared as per the dfu.Based on the information provided and investigation results, the damage to the introducer sheath possibly occurred during use.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the stent during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.

Event Description

Analysis of the returned device noted that the stent had prematurely deployed during use and stent delivery wire (sdw) was broken.No consequences to the patient were reported.

• Brand Name: NEUROFORM 3 EZ- 2.5 X 15MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8474784
• MDR Text Key: 140658166
• Report Number: 3008881809-2019-00087
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H020002
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: M003EN3E25150
• Device Lot Number: 20590972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• 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: XT-27 MICROCATHETER(STRYKER)
• Patient Age: 58 YR