MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number SFR3-4-20-10

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

Patient Problem Vasoconstriction (2126)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The device has been received and device evaluation anticipated, but not yet begun.Upon completion of the device evaluation a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report during procedure a concomitant procedure of ¿intra-arterial nimodipine 3 mg¿ was performed because of severe vasospasm at right cervical ica.The patient underwent mechanical thrombectomy procedure with the solitaire device.The patient had a pre-procedural mtici score of 0 and mtici score following final pass with the solitaire device was 3.There were no reports of patient injury in association with this event.

• Brand Name: SOLITAIRE FR3
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 8226852
• MDR Text Key: 132378266
• Report Number: 2029214-2019-00021
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K153071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: SFR3-4-20-10
• Device Lot Number: A650975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 59