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 Embolism (1829); High Blood Pressure/ Hypertension (1908); Respiratory Failure (2484)

Event Date 04/11/2019

Event Type  Death  

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.The clip delivery system referenced is filed under a separate medwatch report.

Event Description

This is conservatively filed to report possible embolism, resulting in death.It was reported that the initial mitraclip procedure was performed on (b)(6) 2018, to treat functional mitral regurgitation (mr) with a grade of 3-4.A mitraclip was successfully implanted, reducing mr to 1.On (b)(6) 2018, it was noted the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment (slda)) and the mr increased to 3-4.A second intervention was performed on (b)(6) 2019 in an attempt to treat the slda.After the transseptal puncture, the steerable guide catheter (sgc) was advanced to the left ventricle when the patient became unstable.Cardiopulmonary resuscitation was performed however the patient died due to hypoxia.The physician believed an embolism may have occurred but was not confirmed.No additional information was provided.

Manufacturer Narrative

Internal file number - (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 death, hypertension, respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The cause for potential embolism, hypertension, respiratory failure and death is unknown.Although a conclusive cause for the reported patient effect(s), 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
• 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: 8558269
• MDR Text Key: 143368653
• Report Number: 2024168-2019-03353
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80925U239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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): Death