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 Angina (1710); Dyspnea (1816); Edema (1820); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); No Consequences Or Impact To Patient (2199); Heart Failure (2206); Cardiogenic Shock (2262); Test Result (2695)

Event Date 03/07/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed for worsening heart failure, multi-organ failure, and death.It was reported that an initial mitraclip procedure was attempted on (b)(6) 2018 but was discontinued prior to any mitraclip being implanted.The septal puncture site was closed with an asd (atrial septal defect) closure device.On (b)(6) 2018, two mitraclips were implanted without a device issue, reducing the degenerative mitral regurgitation (mr) from grade 3+ to grade 1+.On (b)(6) 2019, the patient was hospitalized for worsening heart failure, increasing dyspnea with a mild cough, lower extremity edema, reoccurring intermittent thorax pain and acute on chronic renal insufficiency.Echocardiogram showed reduced left ventricular ejection fraction (20-25%) with global cardiac hyperkinesia, mitral valve sclerosis with discrete insufficiency and aortic valve sclerosis with insufficiency.The mitraclips remained stable and well seated on the leaflets.A left-right shunt was observed.Reportedly, the mitraclips had not caused or contributed to any tissue damage.The patient had become hypotensive with increased renal insufficiency and developed cardiogenic shock with multi-organ failure.On (b)(6) 2019, the patient expired.The cause of death was cardiovascular.The study physician indicated that it's unknown if the event is device related.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).Based on new information received from the physician that worsening heart failure, hospitalization, cardiogenic shock and multi-organ failure resulting in death was not related to the mitraclip device, this event would not be mdr reportable.Further investigation is not needed.

Event Description

Subsequent to the previous medwatch report, additional information was obtained: per physician, the worsening heart failure requiring hospitalization on (b)(4) 2019, with cardiogenic shock and multi-organ failure resulting in death, was unrelated to the mitraclip device and unrelated to the mitraclip procedure.There was no device malfunction.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and there was no reported device malfunction associated with mitraclip device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, death was a result of procedural circumstances (was cardiovascular and patient had gone into cardiogenic shock with multi-organ failure), and not related to mitraclip device.A definitive cause for the reported patient effects could not be determined.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.Hospitalization and test results are result of case specific circumstances.

• 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: lindsey bell ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8670860
• MDR Text Key: 147065061
• Report Number: 2024168-2019-04427
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 10/17/2019

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: 09/10/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80910U169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 09/27/2019
• Supplement Dates FDA Received: 08/02/2019; 10/17/2019
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 129