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

Catalog Number SGC01ST

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the steerable guiding catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during use of the steerable guiding catheter (sgc), thrombus was observed and the patient experienced cardiac arrest, requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) was advanced, and heparin was administered.The act [activated clotting time] was 200 seconds.15 seconds later, the patient became hypotensive and bradycardic.On echocardiogram, it was observed that the left heart was clotted with thrombus.The heart could not pump; therefore, cardio-pulmonary resuscitation was performed.Additional heparin was administered, and after 5 minutes, the patient improved [act=400 seconds].The procedure was aborted, and the patient went to the critical care unit.It was confirmed that the patient was stable post-procedure.No additional information was 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 that would have contributed to the reported patient effects.The reported patient effects of cardiac arrest, hypotension, and emboli (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 thrombosis was likely a result of the procedural conditions due to the low activated clotting time(act) during advancement of the steerable guide catheter (sgc) into the anatomy.The reported hypotension, bradycardia and subsequent cardiac arrest were likely secondary effects/symptoms of the thrombosis identified in the left atrium and left ventricle, as it was reported that the heart could not pump due to the clots.Based on the information reviewed, 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
• 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: 5890709
• MDR Text Key: 52610038
• Report Number: 2024168-2016-05562
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 51119U129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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): Hospitalization; Life Threatening; Required Intervention