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

Catalog Number SGC01ST

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Ventricular Fibrillation (2130)

Event Date 12/01/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The clip delivery system referenced is filed under a separate medwatch mfr number.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 is filed for death secondary to vena caval injury and retroperitoneal bleeding.It is unknown if the bleed was caused by the transseptal puncture or the steerable guiding catheter.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The patient's anatomy was challenging due to large left chambers, soft septum, and suboptimal transseptal puncture.After placement of the steerable guide catheter (sgc) and clip delivery system (cds), there was difficulty grasping the leaflets.Attempts to grasp the leaflets for over an hour were unsuccessful.After the grasping attempts, the patient's blood pressure decreased.The cds was withdrawn to the left ventricle, but the patient did not recover; therefore, the sgc and cds were withdrawn into the vena cava.The patient experienced ventricular fibrillation, and cardiac arrest.Cardiopulmonary resuscitation (cpr) was initiated and medication was administered; however, the patient expired after approximately 30 minutes of resuscitation attempts.Additionally information reported that the casue of death was retroperitoneal bleeding from the ripped inferior vena cava.It is unknown if the bleed was caused by the transseptal puncture or the sgc.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned and there was no reported device malfunction associated with the steerable guide catheter.The analysis of this complaint was an assessment of the manufacturing records and information provided to abbott vascular.The investigation was unable to determine a definitive cause for this incident.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of cardiac arrest, death, hemorrhage, mitral valve injury, and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effects 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.

Event Description

Subsequent to the initial medwatch report filed, additional information received: autopsy was performed.The inferior vena was ripped.The cause of death was retroperitoneal bleeding from the inferior vena cava.Reportedly the cause of the vena cava damage was not clear; it could be from either the steerable guide catheter or transseptal puncture needle.There was no additional information 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: 5461345
• MDR Text Key: 39077177
• Report Number: 2024168-2016-01131
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• 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,Followup
• Report Date: 03/01/2016

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: 06/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50617U318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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