MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	UNK_NEU
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 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 h3: device evaluated by mfg/ summary attached ¿updated the device history record (dhr) could not be reviewed because the lot number was not reported.However, due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the device revealed that the coil delivery wire was kinked; likely due to handling.The main coil was previously detached.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 (directions for use) 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 or Problem 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: UNKNOWN_NEUROVASCULAR_PRODUCT
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9370245
• Report Number: 3008881809-2019-00366
• Device Sequence Number: 2918166
• Product Code: HCG
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/12/2020

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 Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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: INFINITY SHEATH (STRYKER); SL-10 MICROCATHETER (STRYKER); INFINITY SHEATH (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR