MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device not received for evaluation.

Event Description

It was reported that during the procedure while the stent (subject device) was advanced into the catheter an abnormality was felt.While trying to retrieve the subject stent in the sheath, the device remained in the catheter and only the delivery wire came off.A replacement was used to completed the procedure.The procedure was completed successfully.There were no clinical consequences to the patient.

Event Description

It was reported that during the procedure while the stent (subject device) was advanced into the catheter an abnormality was felt.While trying to retrieve the subject stent in the sheath, the device remained in the catheter and only the delivery wire came off.A replacement was used to completed the procedure.The procedure was completed successfully.There were no clinical consequences to the patient.

Manufacturer Narrative

The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the sdw was kinked bent, the stent was returned deployed within the catheter, and the catheter had to be cut and the stent was retracted from the catheter.It was deformed.During the functional inspection was not performed as stent had deployed in catheter.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The event will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10538579
• MDR Text Key: 207149029
• Report Number: 3008881809-2020-00264
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 21785998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 65 YR