MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036124120

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 mdrs (1st report).

Event Description

It was reported that during stent assisted coiling procedure, physician attempted to put subject coil as the last coil.He repositioned the subject coil two times, however the coil was unable to be advanced or retract as there was a coil tail remaining in the internal carotid artery (ica).Physician used a stent to pin the coil against the vessel wall.He then tried to detach the subject coil but was unable to do so.While he tried removing the delivery wire the subject coil appeared to be stretched.He than had to subsequently use two carotid stents to pin the stretched coil up against the vessel wall.The additional stenting resulted in an hour procedural delay.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during stent assisted coiling procedure, physician attempted to put subject coil as the last coil.He repositioned the subject coil two times, however the coil was unable to be advanced or retract as there was a coil tail remaining in the internal carotid artery (ica).Physician used a stent to pin the coil against the vessel wall.He then tried to detach the subject coil but was unable to do so.While he tried removing the delivery wire the subject coil appeared to be stretched.He than had to subsequently use two carotid stents to pin the stretched coil up against the vessel wall.The additional stenting resulted in an hour procedural delay.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Additional information received on 10-apr-2023 clarified the during the procedure, tail of the subject coil was remaining in the artery.Additional stent was implanted as a medical intervention to tack the coil against the vessel wall.Then the subject coil was stretched, and two more stents were used to tack the coil against the vessel wall.Patient was put on aspirin and plavix.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 1 of 2 mdrs (1st report).B1 adverse event/product problem - updated from adverse even to adverse even and product problem.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/microscopic inspection, only coil delivery wire was returned for analysis.The main coil was not returned.The coil delivery proximal contact was found to be kinked bent.The coil delivery wire was found to be severely stretched and kinked/bent.The coil was found to be detached and not returned.The detachment seems to be mechanical.The coil introducer sheath was not returned.During functional inspection, unable to perform main coil failed/unable to detach functional test as the coil was found to be detached.Main coil friction, main coil stretched, main coil protrusion 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 main coil failed/unable to detach was not confirmed during the analysis; however, the analysis results are consistent with the reported event.The reported main coil protrusion could not be confirmed during the analysis; however, the analysis results are consistent with the reported event.The reported main coil stretched could not be confirmed during the analysis as the coil was not returned.The reported main coil friction could not be confirmed during the analysis as the coil was not returned.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The main coil was found to be detached/separated from delivery wire.The coil was not returned as it stayed implanted.The coil delivery wire was found to be kinked/bent and damaged.An assignable cause of procedural factors will be assigned to the as reported main coil failed/unable to detach, main coil protrusion and as analyzed codes coil delivery wire kinked/bent, coil delivery wire damaged and main coil prematurely detached/separated during use, as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.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 and the main coil was not returned, an assignable cause of undeterminable will be assigned to the as reported codes main coil stretched and main coil friction.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 16186378
• MDR Text Key: 307507172
• Report Number: 3008881809-2023-00021
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 23549489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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: NEUROFORM ATLAS STENT (STRYKER).; UNKNOWN STENTS.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male