MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 22MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036102250
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing 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.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, a cause of undeterminable was assigned to this investigation.Device is not available.
Event or Problem Description
It was reported that during procedure, while deploying a second stent (subject device), the coil prematurely detached within the microcatheter (non-stryker device).The main coil was outside the catheter and the remaining part was entirely inside the microcatheter.The detached coil was completely removed from the patient¿s body by withdrawal of catheter with the coil inside the microcatheter.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The reported lot number was confirmed from the returned packaging.During visual inspection, the proximal contact wire was intact.The coil delivery wire was severely kinked/bent.The main coil was returned detached.The device appeared to be manually detached.The distal tip was found to be intact.The main coil was stretched as.No other anomalies were noted.Functional inspection was not required.The reported defect was confirmed during analysis.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 damage noted to the device would be indicative of the as reported defect.The main coil was seen to be stretched which may have caused the reported event.The reported and analyzed events will be assigned procedural factors as the defect appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent.
Event or Problem Description
It was reported that during procedure, while deploying a second stent (subject device), the coil prematurely detached within the microcatheter (non-stryker device).The main coil was outside the catheter and the remaining part was entirely inside the microcatheter.The detached coil was completely removed from the patient¿s body by withdrawal of catheter with the coil inside the microcatheter.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 22MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9367077
• Report Number: 3008881809-2019-00361
• Device Sequence Number: 421131
• Product Code: HCG
• UDI-Device Identifier: 07613327004748
• UDI-Public: 07613327004748
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2021
• Device Catalogue Number: M0036102250
• Device Lot Number: 20398606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/23/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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: ECHELON 10 MICROCATHETER (COVIDIEN)
• Patient Age: 16 YR