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 Foreign Body In Patient (2687)

Event Date 08/12/2021

Event Type  Injury  

Event Description

It was reported that during the procedure for trans-cell technique, physician placed the subject stent successfully around the left side of ic-pc.While guiding a microcatheter through the subject stent, the proximal marker of the subject stent broke and moved near the distal side of the neck.When the microcatheter was delivered, it was also difficult to guide it into the coil mass as the subject stent was deformed.The subject stent was retrieved using a snare device.The broken fragment of the marker was left inside the patient's anatomy.The procedure was completed and no future treatment is scheduled to remove the broken fragment as there was no effect on blood flow in the patient.Patient's anatomy was average.No other clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during the procedure for trans-cell technique, physician placed the subject stent successfully around the left side of ic-pc.While guiding a microcatheter through the subject stent, the proximal marker of the subject stent broke and moved near the distal side of the neck.When the microcatheter was delivered, it was also difficult to guide it into the coil mass as the subject stent was deformed.The subject stent was retrieved using a snare device.The broken fragment of the marker was left inside the patient's anatomy.The procedure was completed and no future treatment is scheduled to remove the broken fragment as there was no effect on blood flow in the patient.Patient's anatomy was average.No other clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the stent was seen to be broken and deformed.There was no sdw and introducer sheath returned.Functional testing was not carried out due to damage of stent.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.Additional information provided by the customer indicated the device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and the patients anatomy was average.The broken marker of the stent was attempted to be removed with a goose neck snare, the marker remained but there was no effect on the blood flow, so the procedure was completed.The stent was returned deformed and was found to be fractured, based on this the as reported can be confirmed.The as reported ro marker(s) detached/separated/not visible under fluoroscopy, stent deformed, sdw friction and un -retrieved device fragments as well as the as analyzed stent deformed and stent broken/fractured during use will be assigned procedural factors as 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.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12447371
• MDR Text Key: 270554309
• Report Number: 3008881809-2021-00371
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 22810286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2021
• 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
• Treatment: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GOOSENECK SNARE; UNKNOWN COILS; EXCELSIOR SL-10 MICROCATHETER (STRYKER); GOOSENECK SNARE; UNKNOWN COILS
• Patient Outcome(s): Required Intervention; Other
• Patient Race: Asian