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 Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Nausea (1970); Pain (1994); Seizures (2063)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 for post-procedure cerebrovascular accident.It was reported that on (b)(6) 2019, the patient underwent a mitraclip procedure, treating grade 4+ degenerative mitral regurgitation (mr).One clip was implanted; however, the mr remained unchanged at grade 4+.During the procedure, blood pressure dropped to the low 80s/40, but normally ranged 90-105/50-60.Post procedure, the patient experienced nausea and pain, and may have experienced a seizure, caused from the pain.Additionally, the patient experienced right upper arm numbness and weakness, tongue deviation to the right and right upward plantar reflex.Magnetic resonance imaging (mri) confirmed an embolic cerebrovascular accident (cva).Medication was administered, and the patient condition resolved.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).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.The reported patient effects of stroke, hypotension, worsening mitral regurgitation, nausea and pain, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment with medications and hospitalization were likely related to case circumstances.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: 8685145
• MDR Text Key: 147568254
• Report Number: 2024168-2019-04558
• 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: health professional,study
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: 01/02/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 81228U166
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 87