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

Catalog Number	TG5412545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).
Event or Problem Description
It was reported that during a coil embolization procedure for a 4 mm aneurysm was about to be treated without a stent.A microcatheter was guided into the aneurysm, and the first coil and second coil were implanted.However, during the insertion of the third coil (subject device), it did not engage with the mass, and while repositioning it, it became entangled with near the tip of the first coil implanted and made a knot, making it impossible to retrieve the third coil (subject device).While pushing and pulling the third coil (subject device) to untie the knot, the first coil deviated from the mass, and a stent that was not planned to use had to be used.By pushing and pulling the coils, the knot was untied, and the third coil (subject device) was managed to be retrieved.Three additional coils were inserted into the aneurysm and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.However, as a stent was used, the patient will require long-term medication.The extended operative time also resulted in increased radiation exposure.The patient¿s current condition is stable.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 - gtin - corrected.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent.Dried procedural fluid was noted on the main coil which was otherwise intact.During a functional inspection, the main coil was soaked in warm water in an attempt to dissolve the dried procedural fluid, which was only partially successful.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 device difficulty engaging target vessel, device interaction with another device and patient medical or surgical intervention required could not be confirmed during the analysis as they are patient related codes.The reported main coil tangled was not confirmed from the visual inspection.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while repositioning the subject coil as the third coil in the aneurysm, it became entangled with the tip of the first implanted coil and partially pulled it into the parent vessel, where a stent had to be deployed to prevent further migration.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was average, the coil was advanced slowly and gently without applying excessive force, no resistance was encountered inside the catheter shaft, and the same microcatheter was used to finish the procedure.The subject coil was returned for analysis and was found to be intact and attached to the delivery wire.The coil delivery wire was found to be kinked/bent.The first coil was not returned so it could not be determined if this coil contributed to the reported event.Based on the information provided in the complaint, the device appears to have been used as intended.An assignable cause of procedural factors will be assigned to the as reported 'device difficulty engaging target vessel', 'device interaction with another device' and 'patient medical or surgical intervention required' since these issues are 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is most likely due to handling of the product during the clinical procedure.An assignable cause of not confirmed will be assigned to the as reported 'main coil tangled' as the defect was not confirmed during the analysis.
Event or Problem Description
It was reported that during a coil embolization procedure for a 4 mm aneurysm was about to be treated without a stent.A microcatheter was guided into the aneurysm, and the first coil and second coil were implanted.However, during the insertion of the third coil (subject device), it did not engage with the mass, and while repositioning it, it became entangled with near the tip of the first coil implanted and made a knot, making it impossible to retrieve the third coil (subject device).While pushing and pulling the third coil (subject device) to untie the knot, the first coil deviated from the mass, and a stent that was not planned to use had to be used.By pushing and pulling the coils, the knot was untied, and the coil (subject device) was managed to be retrieved.Three additional coils were inserted into the aneurysm and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.However, as a stent was used, the patient will require long-term medication.The extended operative time also resulted in increased radiation exposure.The patient¿s current condition is stable.

• 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: 20212717
• Report Number: 3008881809-2024-00419
• Device Sequence Number: 20783810
• Product Code: HCG
• UDI-Device Identifier: 07613327578621
• UDI-Public: (01)07613327578621(17)260806(10)24472520
• 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): 11/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2026
• Device Catalogue Number: TG5412545
• Device Lot Number: 24472520
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: SL-10 CATHETER (STRYKER); STENT (UNKNOWN); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female