MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0601-XTR

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report thrombosis, neurological deficit and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to <1.Post-procedure, the echocardiogram revealed thrombosis in the left atrium.The physician stated the clip contributed to the thrombosis.Heparin was administered to the patient.It was noted that approximately 4 days post-procedure, the patient has not woken up from the anesthesia.A computed tomography (ct) showed thrombosis in the right carotid.The patient was transferred to another facility for treatment.The thrombosis was successfully extracted through percutaneous transluminal intervention (pti).The clip is stable on both leaflets.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, a definitive cause for the thrombosis could not be determined.In addition, the reported neurological deficit/dysfunction appears to be a result of the thrombus in the right carotid artery.The reported patient effect of mitraclip implant thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8209361
• MDR Text Key: 131826071
• Report Number: 2024168-2019-00014
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2019
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 80723U111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 74