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 Arrhythmia (1721); Bradycardia (1751); Vasoconstriction (2126)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 arrhythmia and vessel spasm (vasoconstriction), 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 effects of bradycardia and arrhythmia appear to be symptoms/secondary effects of the vasoconstriction; however, a cause for the vasoconstriction could not be identified.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After an uncomplicated insertion of the steerable guide catheter (sgc), the patient became hemodynamically unstable.Heart rate initially dropped to 40, then the patient experienced asystole; therefore, cpr was performed and medication provided, which stabilized the patient.It was thought that the event may have been a vasovagal reaction.Once stabilized, the procedure continued with the successful deployment of 1 clip, reducing mr to <1.The patient remained stable post-procedure.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: 7068685
• MDR Text Key: 93258641
• Report Number: 2024168-2017-09239
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• 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
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70828U107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Life Threatening; Required Intervention