MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0303

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is filed for right groin bleeding post procedure. It was reported that on (b)(6) 2018 two mitraclips were implanted, without reported issue, reducing the mitral regurgitation (mr) from severe to mild. That same day while lying flat on the bed, the patient's systolic blood pressure was in the 90's to low 100's and then dropped into the 70's. The patient experienced dizziness and bleeding from the right groin with oozing noted. One liter of normal saline bolus was provided. The patient's blood pressure improved however would intermittently drop again. Two units of packed red blood cells were provided and pressure was held for 30 minutes on the right groin. The bleeding resolved. The event required prolonged hospitalization. The patient was discharged from the hospital on (b)(6) 2018. No additional information was provided regarding this issue.

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. It should be noted that the reported patient effects of hemorrhage requiring transfusion, hypotension and dizziness, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures. Based on the information reviewed, a definitive cause for the reported hemorrhage could not be determined in this case. The reported hypotension and dizziness appears to be the secondary effects of the reported hemorrhage as blood was noted to be oozing at the right groin. 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
• 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: 7995357
• MDR Text Key: 124699263
• Report Number: 2024168-2018-08102
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/04/2019
• Device Catalogue Number: SGC0303
• Device Lot Number: 80104U144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/23/2018 Patient Sequence Number: 1

Treatment

2 IMPLANTED MITRACLIPS