MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035421030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that there was an unknown adverse consequences reported to the patient due to the surgical delay possibly involving coil (subject device).No other information was provided.

Manufacturer Narrative

Section b1: adverse event: corrected no adverse event section b2: outcomes attributed to ae : corrected: no other serious (important medical events), section b5: updated information.Section d: catalog # and lot # - updated from "unknown" to "m0035421030" and "21515181" section h1: type of reportable event - corrected no serious injury section h6: patient code grid: corrected: from "injury" to "no consequences or impact to patient" section d4: expiration date - added section d10/h3: product available to stryker ¿ updated section d10: returned to manufacturer on ¿updated section h3: device evaluated by mfg/ summary attached ¿updated section h4: manufacturing date ¿ added the device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the delivery wire was kinked; likely due to handling.The main coil had been detached previously.The damage to the delivery wire may have caused the reported failure to detach the coil, also analysis of the inzone data shows high impedance conditions which may be an indication of the presence of contrast or embolus to the detachment zone preventing current flow and failure to detach.An assignable cause of procedural factors will be assigned to the reported "main coil failed/unable to detach" as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that there was an unknown adverse consequences reported to the patient due to the surgical delay possibly involving coil (subject device).No other information was provided.Updated based on information received from the site changed the relationship assessment, that there were no adverse events to the patient related to the reported surgical delay and there were no clinical consequences to the patient due to the coil (subject device).

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9153698
• MDR Text Key: 161698039
• Report Number: 3008881809-2019-00301
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: M0035421030
• Device Lot Number: 21515181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITY SHEATH (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 45 YR