MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E40200

Device Problem Premature Separation (4045)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly, and performance specifications.The initial inspection revealed that the stent was returned in its deployed state.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.The stent prematurely deployed outside the patient most likely due to inability to pull back the stent after unsuccessful advancement.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the reported stent difficulty to advance through catheter and to the analyzed stent premature deployment.

Event Description

Based on the investigation of the returned product, the stent (subject device) was deployed prematurely outside patient.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM 3 EZ- 4.0 X 20MM
• 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: 8214377
• MDR Text Key: 132046487
• Report Number: 3008881809-2019-00004
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: M003EN3E40200
• Device Lot Number: 18891376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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
• Patient Age: 56 YR
• Patient Weight: 72