MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER

Model Number SFR2-6-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Neurological Deficit/Dysfunction (1982)

Event Date 04/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was reported to have been discarded at site.Vessel injury is a known inherent risk of mechanical thrombectomy procedure and is documented in the device instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.This event could not be confirmed, as cause could not be definitively determined.

Event Description

Medtronic received information that an internal carotid artery (ica) dissection occurred during the procedure.The patient did have neurological decline at 24 hours post mechanical thrombectomy procedure.Multiple mechanical thrombectomy retrieval attempts were made within the left ica with solitaire fr and competitor thrombectomy devices.The initial tici flow was 0.Post procedure, the tici was 3.The patient was noted to have 2 dissections in the ica.One was present prior to the intervention and the second post intervention.It is unknown when the second dissection occurred or what device caused this event.No additional medical intervention was given for the second dissection.Baseline nihss was 9.At 24 hour assessment the nihss was 18.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLITAIRE FR2
• 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 ; 9492753836
• MDR Report Key: 6019283
• MDR Text Key: 57052055
• Report Number: 2029214-2016-00885
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2017
• Device Model Number: SFR2-6-30
• Device Lot Number: A192165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2015
• 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): Disability
• Patient Age: 79 YR