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

Catalog Number SGC0301

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

Patient Problems Cardiac Arrest (1762); Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Weakness (2145)

Event Date 07/18/2018

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.

Event Description

This report is filed due for post procedure femoral vein bleed, hematoma, disseminated vascular coagulation (dic), and death.It was reported that a mitraclip procedure was performed.One mitraclip was implanted in the patient with degenerative mitral regurgitation (mr) grade 4, reducing the mr to grade 2.There were no device issues.Post-procedure, a femoral venous access site bleed was noted.The patient was too weak for surgery; however, the bleeding was controlled with a femostop device.The femostop device stopped the external bleeding.A computerized tomography scan was performed and a hematoma was noted at the access site.Post-procedure, the patient went into disseminated vascular coagulation (dic).On (b)(6) 2018, the patient had cardiopulmonary arrest and expired.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.It should be noted that the reported patient effects of death, hemorrhage, weakness, coagulopathy and cardiac arrest, as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported weakness was due to the hemorrhage and the hemorrhage appears to be related to procedural conditions.The reported cardiac arrest and subsequent death was due to disseminated vascular coagulation (dic).However, a definitive cause for the dic (coagulopathy) cannot be determined as the account reporter is not willing to discuss the event any further.It is possible that the patients frail condition contributed to the coagulopathy; however, this cannot be confirmed.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: 7769089
• MDR Text Key: 116629792
• Report Number: 2024168-2018-06142
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80410U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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: 78 YR
• Patient Weight: 58