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 Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)

Event Date 05/22/2015

Event Type  Injury  

Event Description

This report is filed for the air embolism during the procedure.It was reported that the mitraclip system was prepared according to the instructions for use.The steerable guide catheter (sgc) was de-aired and maintained the fluid column.After the sgc was inserted in the anatomy, the physician noticed some small air bubbles in the left atrium and left ventricle.The team decided to continue on with the procedure and one mitraclip was implanted centrally on a2/p2.Leaflet insertion was confirmed.After the mitraclip was deployed, the clip delivery system was retracted 10 cm into the sgc.The physician began aspirating a large amount of air while noting a large amount of air bubbles that became one large air bubble in the left ventricle apex.The blood pressure dropped from 120/70 to 60/40.The electrocardiogram showed an atrioventricular block and the pre-existing pacemaker kicked in.Oxygen saturation slowly decreased from 95% to 70%.Dobutamine and noradrenalin were administered to improve the blood pressure.Mitral regurgitation (mr) was reduced from 4 to 3 with one mitraclip.Cerebral axial tomography scan was negative.Mr at the 24 hour echocardiogram improved to 2.The patient was extubated 48 hours after the mitraclip procedure.There was no neurological injury and the patient was stable, but remains in the hospital for a gastrointestinal complication.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: unique device identifier (udi) number: (b)(4).The device was returned for evaluation.Although there was no reported device malfunction/issue, as a conservative measure, the device was analyzed and tested for leaks; no leaks or device malfunction was identified.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 air embolism, arrhythmia 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.

• 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: 4847933
• MDR Text Key: 5807580
• Report Number: 2024168-2015-03314
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/10/2015

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: 09/30/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 40930U112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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): Required Intervention