MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0602-XTR

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

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Edema (1820); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Renal Failure (2041); Heart Failure (2206)

Event Date 04/02/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is not returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is filed due to worsening heart failure, cardiopulmonary arrest, and death.It was reported that on (b)(6) 2019, a mitraclip procedure was performed in a patient with cardiomyopathy and mixed mitral regurgitation (mr) with pure annular dilatation and an anterior leaflet prolapse.Two mitraclips were implanted without a device issue, reducing the mr from grade 4+ to 2+.On (b)(6) 2019, the patient was discharged home.On (b)(6) 2019, the patient was hospitalized for worsening heart failure, dyspnea, and peripheral edema.Diagnostics were performed and medication was provided.Reportedly, on (b)(6) 2019, an echocardiogram was performed.Although incomplete, per physician, the mitraclip had remained in situ, was well seated, and there was no tissue damage due to the clips.Left ventricular function was decreased.Diuretics were increased.On (b)(6) 2019, the patient was hospitalized again for worsening heart failure.The patient also experienced nausea, vomiting, dehydration, hypotension, and acute on chronic renal failure.The patient became hypotensive during the night of (b)(6) 2019, despite fluids provided.The patient was transferred to intensive care and inotropic medications were provided.Some improvement was noted.On (b)(6) 2019, sudden cardiorespiratory arrest occurred, and the patient had gone into pulseless electrical activity.The patient had a no-resuscitation status so no cardiopulmonary resuscitation was performed.Subsequently, the patient expired.No autopsy was performed.Per physician, the cause of death was most likely due to acute renal failure along with non-compaction cardiomyopathy (also known as spongiform cardiomyopathy), although acute mr cannot be ruled out as causative.No additional information was provided regarding this issue.

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 this event.It should be noted that the reported patient effects of death, cardiac arrest, dyspnea, edema, hypotension, nausea, renal failure, heart failure, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects of worsening heart failure, dyspnea, hypotension and renal failure and peripheral edema could not be determined.It is possible it was related to the patient morphology/pathology; however, it cannot be definitively confirmed.Cardiorespiratory arrest was a result of the underlying clinical /patient condition (combined effects of the patient effects).The cause of death was most likely due to acute renal failure along with non-compaction cardiomyopathy.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 XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• 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: 8565516
• MDR Text Key: 143573304
• Report Number: 2024168-2019-03416
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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: 12/07/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 81207U101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 54