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

Catalog Number SGC0302

Device Problem Physical Resistance (2578)

Patient Problems Cardiac Arrest (1762); Thrombosis (2100); Ventricular Tachycardia (2132); Cardiac Tamponade (2226)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (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 additional relevant information.

Event Description

This is filed to report the cardiac arrest requiring cardiopulmonary resuscitation (cpr) and the thrombus.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr) with a grade of 4.The patient presented with atrial fibrillation (af).After introduction of anesthesia the heart rate increased, but continued in af.The steerable guide catheter (sgc) was advanced into the anatomy and difficulty was noted crossing the septum into the left atrium (la).After removal of the dilator, the patient went into ventricular tachycardia (vt) and cardiac arrest, requiring cpr.The rhythm continued to waver between fast af and vt and cpr was continued.After the patient stabilized, thrombosis was seen on the tip of the guide in the left atrium.This resolved with time and activated clotting time (act) management.Two clips were successfully implanted, reducing mr to grade 1.After the procedure, the patient may have experienced cardiac tamponade, but this could not be confirmed and no treatment was provided.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of cardiac arrest, thrombosis, and ventricular tachycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and the reported physical resistance appears to be related to user technique (high tenting).The reported cardiac arrest and ventricular tachycardia was due to procedural conditions (adrenal failure).A definitive cause for the reported thrombus could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the cardiac tamponade did not occur.There was no additional information 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: 7604147
• MDR Text Key: 111142691
• Report Number: 2024168-2018-04496
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80306U222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 50