MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035431020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Premature Separation (4045)

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

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm procedure, the operator used the guidewire to bring the microcatheter to the aneurysm.Next the operator prepared and placed the subject coil to the location.The operator detached the coil and withdrew the delivery wire out.However, when the operator tried to withdraw the microcatheter he found that the proximal of the subject coil adhered to the tip of the microcatheter.The operator used the guidewire to push the coil out but unsuccessfully.The operator withdrew the microcatheter and the subject coil out together.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

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 main coil was returned outside of the microcatheter and the introducer sheath was not returned.The coil delivery wire was seen to be kinked.The main coil was seen to be detached electrolytically.The main coil was seen to be severely stretched.A 0.0160 mandrel was advanced through the microcatheter with no difficulties.Considerable procedural fluid was noted on the device.During functional inspection a 0.0160 mandrel was advanced through the flushed microcatheter to insure nothing else remained.No damage noted.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 confirmed; 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.Based on the information provided, the main coil was successfully placed in the aneurysm and detached.During removal of the coil, it appeared to have become jammed in the microcatheter tip.It¿s possible that the main coil was not advanced far enough from the microcatheter tip prior to detachment and remained inside the tip after detachment.However, this cannot be conclusively determined.The returned device was analyzed, and the results are consistent with the reported event.The main coil was found to be damaged proximally.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.Therefore, an assignable cause of procedural factors will be assigned to all reported events: ¿coil jammed', 'device interaction with another device', 'patient medical or surgical intervention required' and the analyzed event: 'main coil stretched'.An assignable cause of handling damage will be assigned to the analyzed event 'coil delivery wire kinked/bent¿ as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm procedure, the operator used the guidewire to bring the microcatheter to the aneurysm.Next the operator prepared and placed the subject coil to the location.The operator detached the coil and withdrew the delivery wire out.However, when the operator tried to withdraw the microcatheter he found that the proximal of the subject coil adhered to the tip of the microcatheter.The operator used the guidewire to push the coil out but unsuccessfully.The operator withdrew the microcatheter and the subject coil out together.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Additional information was received on 14-feb-2024 stated that the subject coil was not prematurely detached during use.It was detached normally and then because of the reported issue it was taken out.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 18664506
• MDR Text Key: 334832523
• Report Number: 3008881809-2024-00050
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153658
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0035431020
• Device Lot Number: 24299247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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: SYNCHRO GUIDEWIRE (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Race: Asian