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

Catalog Number SGC0301

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

Patient Problems Embolism (1829); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned as it was discarded.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of emboli and thrombus (thrombosis) as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of embolism appears to be related to procedural conditions, and due to the clot that broke free during aspiration attempts; however, a cause for the clot (thrombus) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the clot.It was reported that the patient, with grade 4+ degenerative mitral regurgitation (mr), underwent a mitraclip procedure.The patient had a pre-existing inferior vena cava (ivc) filter.The steerable guide catheter was advanced through the femoral vein and was able to maneuver around the ivc filter.The sgc was advanced through the inferior vena cava and into the right atrium.It was then noted that there was a clot at the tip of the sgc.It was thought that the clot had been picked up when passing the ivc filter, but this could not be confirmed.Aspiration attempts were made and the dilator and guide wire were pulled back in an attempt to remove the clot, but the clot could not be aspirated.The clot then broke free.The patient was heparinized to an activated clotting time (act) of above 250 and the procedure continued.Two mitraclips were implanted and the mitral regurgitation (mr) was reduced to grade 1+.At the end of the procedure, it was noted that the patient was not responding and there was difficulty waking the patient.It was not clear if the patient was slow to come out of anesthesia or if the patient had experienced a stroke or transient ischemic attack (tia), as a result of the clot.The stroke team was called in for evaluation and the patient was taken for a computed tomography (ct) scan.Ct scan noted no signs of stroke and no additional intervention was required.The physician attributed the slowness coming out of anesthesia to the patient's age and the patient has had no remaining effects.Post procedure, the patient was in stable condition.No additional information was provided.

• 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6815866
• MDR Text Key: 83463299
• Report Number: 2024168-2017-06903
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70327U118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: 81 YR