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

Catalog Number M003EZAS45210

Device Problem Fracture (1260)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure, the physician encountered resistance while delivering the subject stent in the micro catheter.While withdrawing the subject stent, it was difficult to retract it back into the sheath.When the subject stent was taken out of the y-valve, its distal part was broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Event Description

It was reported that during the procedure, the physician encountered resistance while delivering the subject stent in the micro catheter.While withdrawing the subject stent, it was difficult to retract it back into the sheath.When the subject stent was taken out of the y-valve, its distal part was broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

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 confirmed from the packaging label.On visual inspection, the sdw was kinked bent and broken/fractured.The sheath returned within a non atlas sheath.The stent was removed from the sheath and was seen to be deformed.Functional inspection was not carried out as stent had deployed.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 as reported stent difficult/unable to pull stent back in to sheath will be assigned user error as the atlas stent is not re sheathable.The sdw was seen to be kinked bent and was broken, the stent was also deformed.The as reported stent difficult/unable to advance/pullback through catheter and stent broken/fractured during use as well as the analyzed sdw kinked/bent, sdw broken /fractured during use and stent deformed 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 4.5MM 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: 10593735
• MDR Text Key: 208784062
• Report Number: 3008881809-2020-00277
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 22312654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR SL-10 MICRO CATHETER (STRYKER); EXCELSIOR XT- 17 MICRO CATHETER (STRYKER); EXCELSIOR SL-10 MICRO CATHETER (STRYKER); EXCELSIOR XT- 17 MICRO CATHETER (STRYKER)
• Patient Age: 48 YR
• Patient Weight: 75