MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 3.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E30200

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2019

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 was deformed and was prematurely deployed during use.The functioning test could not be performed due to the condition of the returned device.As per additional information received the patient¿s anatomy was moderately tortuous, which may have caused or contributed to the reported event.The stent deformed most likely during attempted advancement in the microcatheter, due to some procedural factors encountered.This complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.Therefore, a probable cause of procedural factors will be assigned to the reported event and analyzed defects.

Event Description

During the analysis of the returned device, it was revealed that the stent was prematurely deployed during use.No clinical consequences reported to the patient.

• Brand Name: NEUROFORM 3 EZ- 3.0 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: 9254010
• MDR Text Key: 164632749
• Report Number: 3008881809-2019-00326
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Catalogue Number: M003EN3E30200
• Device Lot Number: 21225538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2019
• 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: 53 YR
• Patient Weight: 59