MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Thrombosis (2100); Visual Disturbances (2140)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report thrombosis/stroke.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.During the procedure, thrombus was noted on the tip of the steerable guide catheter (sgc).Two clips were implanted on the without issue, reducing the mr to 1.Approximately 3 1/2 hours post procedure the patient suffered a stroke resulting in hemiparesis and hemianopsia.The stroke is reported to be due to thrombus formation on the sgc, in spite of an activated clotting time of >300.The patient is still experiencing hemianopsia (visibility issues), but is reported to be getting better.No treatment was performed as the patient was already on anticoagulants pre-interventionally.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: there was no reported issue with the mitraclip system during use.Thrombus was not observed during the procedure; however, it was believed that there was thrombus on the steerable guide catheter (sgc), which remained in the atrium and later embolized.The patient is no longer hospitalized.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of cerebrovascular accident (stroke) and emboli (thrombus) as listed in the mitraclip system instructions for use (ifu), are known possible complication associated with mitraclip procedures.The reported embolism appears to be due to the thrombosis.The reported stroke appears to be due to embolism as the thrombus embolized in the atrial septum during steerable guide catheter retraction.The reported visual disturbances appear to be due to the stroke.Although a conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7409574
• MDR Text Key: 104777048
• Report Number: 2024168-2018-02584
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70925U141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO (2) IMPLANTED MITRACLIPS; TWO (2) IMPLANTED MITRACLIPS
• Patient Outcome(s): Disability
• Patient Age: 78 YR