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 Atrial Perforation (2511); Test Result (2695)

Event Date 05/13/2019

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.The other steerable guide catheter (80723u203) device is filed under a separate medwatch report number.

Event Description

This is filed to report a leak, atrial perforation, and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.During preparation of the first steerable guide catheter (sgc 80723u203) while inserting the dilator, a leak was observed.Preparation was attempted five times, but the sgc continued to leak.The sgc was not used in the patient, and was replaced.The second sgc (80924u146) was advanced to the mitral valve.Next the first clip delivery system (cds) was advanced and it was noted that the patients oxygen level dropped.The oxygen level was controlled by the anesthesiologist.The procedure was continued, and the clip was deployed.As the cds was being removed, a shunt in both directions was observed.The physician stated the drop in oxygen level was associated to the shunt.A second clip (80905u147) was advanced to the mitral valve to further reduce mr; however, the clip would not open smoothly when the lock lever was pulled to position of the blue line and the lock line was loose.Trouble shooting was performed, and the clip was able to open.The clip was deployed and the cds was removed.The shunt was treated with an atrial septal defect (asd) closure device.Two clips were implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (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, there is no indication of a product quality issue.The reported atrial perforation appears to be due to user technique/procedural circumstances.The reported abnormal test result (dropped oxygen saturation) was due to the reported perforation.The reported patient effect of atrial perforation and abnormal test results (decreased oxygen level) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, 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
• MDR Report Key: 8663123
• MDR Text Key: 146811748
• Report Number: 2024168-2019-04299
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80924U146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM, 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM, 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 58