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

Catalog Number SGC0302

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

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Ventricular Tachycardia (2132)

Event Date 07/03/2018

Event Type  Injury  

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 additional relevant information.

Event Description

This is filed to report an air embolism noted in the right atrium.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and pre-existing chordal rupture.The vena cava was noted to be tortuous.The steerable guiding catheter (sgc 80124u134) was advanced into the anatomy, but kinked.The sgc was removed and was replaced with a new sgc (80316u120).The first clip delivery system (cds 80312u252) was advanced to the mitral valve.The clip was implanted, reducing the mr to 2-3.The second cds (80309u185) was advanced; however, the clip got caught on the chordae and could not be freed from the chordae.Due to the situation in the right heart, the clip was implanted on the leaflets and chordae; mr increased to 3.There was possible tissue damage lateral from the pre-existing chordal rupture.The patient experienced hypotension and ventricular tachycardia, and air embolism was noted in the right atrium (ra).Medication was used to treat the hypotension.Aspiration was performed; however, no air was removed in the syringe.After the devices were removed from the anatomy, they were tested, but no leak was observed.There was no clinically significant delay during the procedure.The patient is stable.No additional information was provided.

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.Based on the information reviewed, a definitive cause for the air embolism cannot be determined.The hypotension and ventricular tachycardia however, were likely cascading effects of the air embolism.The reported patient effects of emboli (air), hypotension and arrhythmias (ventricular tachycardia), as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effect, 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: 7718358
• MDR Text Key: 114972873
• Report Number: 2024168-2018-05739
• Device Sequence Number: 1
• Product Code: DRA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80316U120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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: CLIP DELIVERY SYSTEM, 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR