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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Occlusion (1984)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported patient effects of air emboli, bradycardia and hypotension as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and the reported leak appears to be related to user technique of cds insertion.The reported air embolism was a result of procedural conditions and the occlusion, bradycardia and hypotension were cascading effects of the air embolism.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.The clip delivery systems referenced in b5 are filed under separate medwatch report numbers.

Event Description

This is filed to report the air emboli that occurred.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3-4.During insertion of the first clip delivery system (cds 70221u189), air was noted in the steerable guide catheter (sgc).It was believed that the clip may have been advanced a few millimeters out of the introducer while inserting into the sgc.The air was aspirated, but the patient became hypotensive with reduction in ejection fraction of the right ventricle and increased pressure in the vena cava.The procedure was stopped, and the mitraclip system was left in place.Angiography found a total occlusion of the right coronary artery (rca).Aspiration was performed and the patient was reanimated and defibrillated several times.After removing the air and giving medication, the patient became hemodynamically stable.The cds was attempted to be removed to replace the device; however, one clip arm was getting stuck with the clip introducer; therefore, the procedure was continued with the same devices and the clip was implanted.The second clip(70221u180) was implanted which resulted in a pressure gradient increase of 8mmhg.The mr was reduced to <1.The pacemaker rate was reprogrammed to prevent mitral stenosis symptoms.A clinically significant delay was noted due to the air embolism.On (b)(6) 2017, the patient was extubated and doing well with no neurological issues.No additional information was 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: 6635821
• MDR Text Key: 77393581
• Report Number: 2024168-2017-05004
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216831
• UDI-Public: (01)08717648216831(17)180308(10)70307U115
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70307U115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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): Life Threatening; Required Intervention