MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil insertion with considerable speed in and out caused the coil (subject device) to stretch at distal.After that, subsequent attempts were made to retrieve the coil (subject device); however, it was difficult.A snare and forceps type was used to retrieve the coil (subject device).Eventually, it was retrieved without remaining in the body, but a thrombus was confirmed in the inguinal region.The causal relationship between the coil (subject device) and the thrombus was unknown.The patient was re-treated at a later date.The thrombus was successfully treated and the re-treatment was completed.There was a surgical delay for four hours.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation 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 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.Additional information provided by the customer indicated that no damage was noted to the packaging prior to opening the packaging.The device was prepared for use as per the directions for use.However, continuous flush was not set up and maintained throughout the clinical procedure, excessive force was applied while advancing the coil and the coil was not advanced slowly and gently.The patient¿s anatomy was described as 'very meandering'.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter.An assignable cause of use error will be assigned to this complaint, as there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
It was reported that during coil insertion with considerable speed in and out caused the coil (subject device) to stretch at distal.After that, subsequent attempts were made to retrieve the coil (subject device); however, it was difficult.A snare and forceps type was used to retrieve the coil (subject device).Eventually, it was retrieved without remaining in the body, but a thrombus was confirmed in the inguinal region.The causal relationship between the coil (subject device) and the thrombus was unknown.The patient was re-treated at a later date.The thrombus was successfully treated and the re-treatment was completed.There was a surgical delay for four hours.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 16MM X 50CM
• 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: 14379962
• Report Number: 3008881809-2022-00220
• Device Sequence Number: 4990485
• Product Code: HCG
• UDI-Device Identifier: 07613327128352
• UDI-Public: 07613327128352
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 07/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2024
• Device Model Number: M0036181650
• Device Catalogue Number: M0036181650
• Device Lot Number: 23039724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: EXCELSIOR 1018 (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown