MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the subject coil was repositioned before it deployed in the aneurysm, and the proximal part of the coil was stretched.The physician then used a microcatheter and a snare device to remove the stretched coil from the patient¿s anatomy.There were no clinical consequences reported due to this event.
Event or Problem Description
It was reported that when the subject coil was repositioned before it deployed in the aneurysm, and the proximal part of the coil was stretched.The physician then used a microcatheter and a snare device to remove the stretched coil from the patient¿s anatomy.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the target coil was still attached to the snare device and was emerging from the catheter.The main coil was noted to be kinked/bent and stretched.The proximal contact was not returned with the device and the coil delivery wire could not be analyzed as it was within the catheter and could not be removed.Functional testing could not be performed due to the anomalies noted to the coil.In case of this complaint, the damage noted to the device are indicative of the as reported defect.The main coil was noted to be stretched and medical intervention was required to obtain the stretched main coil; therefore, an assignable cause of procedural factor was assigned to the as reported issue patient medical intervention required, as the reported event appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural or anatomical factors during use.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8295186
• Report Number: 3008881809-2019-00037
• Device Sequence Number: 1500631
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: 04546540676481
• 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): 04/16/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: M0035474150
• Device Lot Number: 20318624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR