MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E30150

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the stent had partially deployed.Functional testing did not reveal any anomalies.The risk of the issue is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based on the information available, it is likely the device was damaged during the clinical procedure, due to the tortuousity of the patients anatomy that caused premature deployment of the stent.Therefore, a cause of procedural factors will be assigned to the investigation as the product performance was limited due to procedural and/or anatomical factors during use.

Event Description

Analysis of the returned device found that the stent had partially deployed.There was no clinical consequence to the patient as a result of this event.

• Brand Name: NEUROFORM 3 EZ- 3.0 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: 9101385
• MDR Text Key: 159519626
• Report Number: 3008881809-2019-00287
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Catalogue Number: M003EN3E30150
• Device Lot Number: 21131809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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: 58 YR
• Patient Weight: 60