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 Thrombosis (2100); Tissue Damage (2104)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The two clip delivery systems are filed under separate medwatch reports.

Event Description

This is filed to report the thrombus and tissue damage.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter (sgc) was inserted and the first clip (80222u118) was advanced to the mitral valve leaflets and positioned.During deployment when the actuator knob was pulled, the knob and the actuator mandrel came out of the system; however, the clip deployed successfully.At this point, a structure was visible on the tip of the sgc (could have been thrombus and/or tissue).The procedure continued and a second clip (80221u150) was positioned.During deployment when the actuator knob was pulled, the knob and actuator mandrel came out of the system.The clip still deployed successfully, reducing mr to 1.When the cds was removed, the thrombus or tissue disappeared.It was commented that the actuator knob may have been pulled too hard.The patient remained stable.There was no reported adverse patient sequela or a clinically significant delay during the procedure.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 information reviewed, a definitive cause for the reported thrombosis and tissue damage could not be determined in this incident.The reported patient effects of mitral valve tissue damage and thrombus are listed in the mitraclip system instructions for use as known possible complication 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: 8072406
• MDR Text Key: 127199141
• Report Number: 2024168-2018-08818
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80725U157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• 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
• Patient Outcome(s): Required Intervention