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

Catalog Number M003EZAS30210

Device Problem Fracture (1260)

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

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during an acoma (anterior communicating artery) aneurysm procedure, when the subject stent was partially advanced into the microcatheter, the physician felt friction and the subject stent could not be advanced anymore after several tries.The subject stent was withdrawn and deployed on the table but big force was required to remove the subject stent out of the microcatheter and the subject stent was found to be deformed.The microcatheter was replaced as the subject stent was fractured inside of the microcatheter.The physician replaced the subject stent with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 returned to manufacturer on - updated d9 product available to stryker ¿ updated there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the stent was found to be deployed.The stent was deployed by the operator on the table, after the procedure.The stent was found to be broken/fractured and deformed.The introducer sheath distal tip was found to be damaged.The sdw (stent delivery wire) was found to be kinked/bent.As the stent was returned deployed a functional inspection could not be performed.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 stent difficult/unable to advance or pullback through catheter could not be replicated; however, the analysis results are consistent with the reported event.The reported stent broken/fractured during use and stent deformed were confirmed during the analysis.The device did not meet specifications when received for complaint investigation based on visual inspection.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'moderately torturous'.The device was analyzed.The stent was found to be broken/fractured and deformed.The sdw was found to be kinked/bent.The tip of the stent introducer sheath was found to be damaged.It is probable that the moderately tortuous anatomy may have caused friction and reported defects during use.An assignable cause of procedural factors will be assigned to the as reported events of stent difficult/unable to advance or pullback through catheter, stent deformed and stent broken/fractured during use, and to the as analysed events of introducer sheath distal tip damaged, stent deformed, stent broken/fractured during use, sdw kinked/bent 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 an acoma (anterior communicating artery) aneurysm procedure, when the subject stent was partially advanced into the microcatheter, the physician felt friction and the subject stent could not be advanced anymore after several tries.The subject stent was withdrawn and deployed on the table but big force was required to remove the subject stent out of the microcatheter and the subject stent was found to be deformed.The microcatheter was replaced as the subject stent was fractured inside of the microcatheter.The physician replaced the subject stent with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'moderately torturous'.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported event.

Event Description

It was reported that during an acoma (anterior communicating artery) aneurysm procedure, when the subject stent was partially advanced into the microcatheter, the physician felt friction and the subject stent could not be advanced anymore after several tries.The subject stent was withdrawn and deployed on the table but big force was required to remove the subject stent out of the microcatheter and the subject stent was found to be deformed.The microcatheter was replaced as the subject stent was fractured inside of the microcatheter.The physician replaced the subject stent with a new device and continued the procedure without clinical consequences to the patient.

• 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
• 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: 17113964
• MDR Text Key: 317578451
• Report Number: 3008881809-2023-00296
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 23784964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 08/24/2023
• Supplement Dates FDA Received: 07/28/2023; 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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 MICROCATHETER (MEDTRONIC).; EXCELSIOR SL-10 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Race: Asian