MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS45210

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

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.The device was received.The reported lot number was not confirmed as the packaging was not returned.During the visual inspection, the stent device was returned within the catheter.There were no anomalies noted on the catheter.The stent delivery wire was kinked bent distally and proximally.The stent had deployed and was not returned.Functional testing not done as the stent was not returned.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 stent delivery wire was seen to be kinked bent and the stent was not returned and presumed deployed.The as reported event can be confirmed based on the analysis.The as reported and as analyzed stent delivery wire kinked bent and stent deployed prematurely during use will be assigned procedural factors this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

It was reported that during the procedure while the physician was unsheathing the subject stent the pusher wire got kinked.The stent was taken out along with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the device revealed that the stent deployed prematurely during use; therefore, based on this information the event is deemed reportable and emdr will be filed with an awareness date of 20-jul-2020.The event will be assessed to reflect the decision change and emdr will be filed accordingly.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 10365583
• MDR Text Key: 201709816
• Report Number: 3008881809-2020-00229
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382150
• UDI-Public: 07613327382150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS45210
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: 21536782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• 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
• Patient Age: 60 YR