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 02/20/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure, resistance was encountered when advancing the stent (subject device) into the microcatheter hub and force was required to insert it.Resistance increased as the stent was advanced in the microcatheter.The physician withdrew the stent and deployed it on the table where it was found to be broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was seen to be deployed.The stent delivery wire (sdw) was seen to be kinked.The stent struts were seen to be broken and the stent was seen to be deformed.The introducer sheath was returned intact.The functional inspection could not be performed as the stent was returned 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 reported event of stent broken/fractured during use was confirmed during analysis.The reported event of stent difficult/unable to advance or pullback through catheter and stent difficult/unable to transfer could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received was the device was prepared 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 prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was analyzed.The stent was returned in the condition of deployed, however it was reported the stent was deployed on the table by the physician.The stent was also found to be deformed and broken/fractured.The sdw was returned and found to be kinked and the introducer sheath was returned and was found to be intact.Its likely when the reported resistance was felt while attempting to transfer the stent during the procedure manipulation of the device, would have caused the damage noted to the device during analysis.The reported events stent difficult/unable to advance or pullback through catheter, stent difficult/unable to transfer and stent broken/fractured during use as well as the analyzed defects stent broken/fractured during use, sdw kinked/bent 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.

Event Description

It was reported that during the procedure, resistance was encountered when advancing the stent (subject device) into the microcatheter hub and force was required to insert it.Resistance increased as the stent was advanced in the microcatheter.The physician withdrew the stent and deployed it on the table where it was found to be broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 16523222
• MDR Text Key: 311111618
• Report Number: 3008881809-2023-00123
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 23604190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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: COIL (UNKNOWN); ECHELON-10 CATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: Asian