MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problems Component Missing (2306); Premature Separation (4045)

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

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Device not received for evaluation.

Event Description

It was reported that during the procedure located at batop when delivering the stent (subject device), under fluoroscopy the subject stent marker could not be seen.The catheter was removed and lumen confirmed, but the physician could not find the device.The device was exchanged out and the procedure was completed successfully.There were no clinical consequences to the patient.

Event Description

It was reported that during the procedure located at batop when delivering the stent (subject device), under fluoroscopy the subject stent marker could not be seen.The catheter was removed and lumen confirmed, but the physician could not find the device.The device was exchanged out and the procedure was completed successfully.There were no clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.In the case of this complaint it is likely that the stent was deployed prematurely during preparation or use and deployment was not noted, this however cannot be conclusively determined.Additional information indicates no damage was noted to the device packaging and the dfu was used during preparation /prior to procedure.During device manufacture components are electronically scanned to ensure the component is present.In addition confirmation that the stent is loaded is verified.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.H3 other text : device not returned for evaluation.

• Brand Name: NEUROFORM ATLAS 4.0MM 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: 10538581
• MDR Text Key: 207134905
• Report Number: 3008881809-2020-00263
• 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: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 21682536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (UNKNOWN); MICROCATHETER (UNKNOWN)