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

Catalog Number SGC01ST

Device Problem Physical Resistance (2578)

Patient Problems Atrial Flutter (1730); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 04/27/2015

Event Type  Injury  

Event Description

This is conservatively filed to report the bleeding that occurred during use with a non-abbott dilator.The steerable guiding catheter cannot be excluded as possibly contributing to the worsening of bleeding, requiring medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The groin was pre-dilated with 2 non-abbott dilators.During insertion of the steerable guiding catheter (sgc), resistance was noted with the anatomy.The sgc was moved back and forth, and removed.Dilatation was performed, and the sgc was easily advanced.The clip delivery system (cds) was inserted and advanced to the mitral valve without issue.The leaflets were grasped successfully; however, the systolic blood pressure increased from 100 to 140.The clip was deployed and the mr was reduced to 2.Immediately after removing the cds, the systolic blood pressure dropped to 80, 60, then 40.It was unclear what happened.Heart rate was irregular, but the leads of the crt device were still in place.Hemoglobin dropped from 11 to 8.The patient was given blood, and administered suprarenin.The blood pressure returned to normal.A second cds was then used to finish the procedure, and the blood pressure and heart rate were stable.Two clips were implanted and the mr was reduced to 1.The patient was extubated a few hours later and was stable the next morning.A peritoneal bleed was confirmed on (b)(6) 2015.A perforation was seen above where the puncture was performed; therefore, it was suspected that the bleed was caused by one of the dilators.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: dilator (edwards 16f, edwards 18f, cook 18f, mitraclip system, steerable guide catheter, 2 implanted mitraclips.The steerable guide catheter was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records/complaint history and information provided to abbott vascular.Potential causes for physical resistance while inserting the steerable guiding catheter (sgc) can include, but are not limited to, patient conditions, user technique / procedural conditions, or manufacturing anomalies.With respect to patient conditions and/or procedural conditions / user technique, physical resistance while inserting the guide may be influenced by tortuous / challenging anatomy or insufficient dilation of the vein.Based on the information reviewed, the resistance during sgc insertion was a result of user technique / procedural conditions.The patient effects of arrhythmia, hemorrhage, hypertension, and hypotension are listed in the mitraclip system instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on the information, a definitive cause for the reported arrhythmia, hypertension, or hypotension could not be definitively determined; however, the reported hemorrhage was likely associated with procedural conditions during dilator insertion.This event was further reviewed by an abbott vascular senior medical advisor.The reviewer noted that the arrhythmia was associated with the patient underlying condition.The hemodynamic changes seen as the changes in blood pressure are attributed to the reduction in mitral regurgitation with successful clip implantation.In select patients who have left ventricular dysfunction the reduction in blood flow due to the clip on the valve is not well tolerated.The patient in this incident is one of those.None of these events are associated with a product quality issue.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a manufacturing issue.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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4774848
• MDR Text Key: 5805541
• Report Number: 2024168-2015-02762
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50116U108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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