MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412545
Medical Device Problem Codes	Expulsion (2933); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during coil embolization for unruptured aneurysm procedure in the basilar artery, the operator placed the coil in the aneurysm and with the coil still being attached, the operator advanced the stent to the target site.After the stent was deployed, the coil was detached.Next, the subject coil was delivered into the aneurysm.When the operator heard the normal beep sound from the power supply which signaled a successful coil detachment, the delivery wire was retracted and the subject coil in the aneurysm moved during the retraction.Next, the third coil was advanced through the microcatheter, but due to big resistance during the delivery it was retracted together with the catheter.During the retrieval the coils moved to the area between the aneurysm.Angiography revealed that a wire was left in the vessel between the basilar artery and the vertebral artery.Surgical delay of 120 minutes was reported.The procedure was completed successfully.No further information available.
Event or Problem Description
It was reported that during coil embolization for unruptured aneurysm procedure in the basilar artery, the operator placed the coil in the aneurysm and with the coil still being attached, the operator advanced the stent to the target site.After the stent was deployed, the coil was detached.Next, the subject coil was delivered into the aneurysm.When the operator heard the normal beep sound from the power supply which signaled a successful coil detachment, the delivery wire was retracted and the subject coil in the aneurysm moved during the retraction.Next, the third coil was advanced through the microcatheter, but due to big resistance during the delivery it was retracted together with the catheter.During the retrieval the coils moved to the area between the aneurysm.Angiography revealed that a wire was left in the vessel between the basilar artery and the vertebral artery.Surgical delay of 120 minutes was reported.The procedure was completed successfully.No further information available.
Additional 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 coil delivery wire was noted to be kinked.The main coil was not returned and looked like it was detached using an inzone.The coil introducer sheath was not returned.Functional inspection was not performed as the main coil was not returned.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 not confirmed based on the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer, the device was prepared for use as per the dfu.Continued flush was set up and maintained throughout the procedure.There was no damage noted to the packaging prior to opening the packaging.The customer also was concerned the coil was shorter than 3cm but could not be analysed to confirm this defect as it was not returned.The patient¿s anatomy was normal.During analysis the coil delivery wire was returned kinked and the main coil looked to be detected electronically and not returned for analysis.The coil introducer sheath was also not returned.An assignable cause of procedural factors will be assigned to the reported event ¿main coil migration¿ as these defects 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.An assignable cause of undeterminable was assigned to the reported event ¿main coil incorrect dimension¿ as the main was looked to be detached using an inzone and was not returned for analysis.An assignable cause of 'handling damage' will be assigned to the analysed event ¿coil delivery wire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during preparation.An assignable cause of procedural factors will be assigned to the analysed event ¿main coil prematurely detached/separated during use¿ as these defects 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.

• Brand Name: TARGET TETRA 2.5MM X 4.5CM
• Common Device Name: 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: 18203650
• Report Number: 3008881809-2023-00562
• Device Sequence Number: 15014569
• Product Code: HCG
• UDI-Device Identifier: 07613327578621
• UDI-Public: 07613327578621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2026
• Device Catalogue Number: TG5412545
• Device Lot Number: 24176422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER (UNKNOWN); NEUROFORM ATLAS STENT (STRYKER)
• Patient Sex: Unknown