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 Problem Thrombosis (2100)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of thrombus is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is being filed under a separate medwatch report.

Event Description

This is filed to report the thrombus.It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) grade 3.The patient had history on heparin induced thrombocytopenia (hit); therefore, a heparin alternative was used during the procedure.After the transseptal puncture was performed and the guide wire was positioned in the left atrium, thrombus was observed at the septum in the right atrium, on the guide wire.Medication was increased and the thrombus was aspirated.There was no presence of the thrombus; therefore, the steerable guide catheter (sgc) and clip delivery system (cds) were advanced to the left atrium.While positioning the cds, thrombus was observed on the clip.The clip was not implanted and the cds was removed.Outside the anatomy, the thrombus was still attached to the clip.The sgc was retracted to the right atrium and a 4 cm long thrombus was attached to the tip of the sgc.The thrombus was aspirated and the sgc was removed.No further treatment was attempted, and the procedure was discontinued.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: 8399620
• MDR Text Key: 138108834
• Report Number: 2024168-2019-01766
• 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
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81008U146
• 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: 10/01/2018
• 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
• Patient Outcome(s): Required Intervention