MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432060
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when the coil (subject device) was not deployed during bae (basilar artery embolization) was done for the superior thoracic artery and the resistance was felt.The physician attempted to withdraw the coil (subject device) by using the microcatheter (stryker) but the coil was not moved, and the stretch of the coil was confirmed under fluoroscopy.The resistance was felt at sheath part.Therefore; the guiding catheter (non-stryker) was used to retrieve the coil along with the microcatheter.Upon removal, the coil had detached in the microcatheter by fluoroscopy, and the coil could not be confirmed at out of the body.After retrieving the coil, it was confirmed under fluoroscopy that the proximal of the coil was protrude from the coil mass.No further information is available.
Additional Manufacturer Narrative
A review of the device history record confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found that the delivery wire was bent from the proximal end and on the firm coil section.There was evidence of electrolytic detachment of the main coil at the detachment zone, not confirming the "main coil prematurely detached inside patient.A functional test was unable to be performed as the main coil was detached from the delivery wire.As per the additional information there was very tortuous anatomy.It is probable that the tortuous nature of the patients anatomy caused the reported issues.Therefore, an assignable cause of procedural factors has been be assigned to the reported event and analyzed anomalies as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that when the coil (subject device) was not deployed during bae (basilar artery embolization) was done for the superior thoracic artery and the resistance was felt.The physician attempted to withdraw the coil (subject device) by using the microcatheter (stryker) but the coil was not moved, and the stretch of the coil was confirmed under fluoroscopy.The resistance was felt at sheath part.Therefore; the guiding catheter (non-stryker) was used to retrieve the coil along with the microcatheter.Upon removal, the coil had detached in the microcatheter by fluoroscopy, and the coil could not be confirmed at out of the body.After retrieving the coil, it was confirmed under fluoroscopy that the proximal of the coil was protrude from the coil mass.No further information is available.Update patient information : received additional information stated that the patient¿s current condition is stable.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8737657
• Report Number: 3008881809-2019-00185
• Device Sequence Number: 16787275
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 09/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2021
• Device Catalogue Number: M0035432060
• Device Lot Number: 21055359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE MEISTER/16/ASAHI (NON STRYKER); SHEATH 5F/TERUMO (NON STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR