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 Problems Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/13/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the patient death.It was reported that on (b)(6) 2018 the mitraclip procedure was intended to be performed in the patient with a fragile state of health and grade 4 degenerative mitral regurgitation (mr).At the start of the procedure, the arterial pressure was approximately 9 to 10 mm hg.During advancement of the steerable guide catheter (sgc), the femoral vein was perforated.There was no resistance felt during advancement of the sgc through the femoral vein, but it is surmised that the physician applied too much force to the sgc during advancement and it went too far and the guide wire was not kept straight during advancement.The procedure was aborted and no mitraclip was implanted due to this adverse event.The arterial pressure dropped down to 3 mm hg.The bleeding was controlled by keeping the sgc in place while the patient was transferred to surgery to repair the femoral lesion.A covered stent was placed and the perforation was sutured.After surgery, the arterial pressure increased to 12 mm hg.The patient expired on (b)(6) 2018 from an unknown cause.There was no issue reported with the device.No additional information was provided.

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.The reported patient effects of hemorrhage, hypotension, cardiac perforation and death as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medical affairs director.The reviewer concluded that the procedure was conducted in a patient in a fragile condition and led to a complication during advancement of the sgc (steerable guide catheter) resulting in femoral vein complication.Despite surgical repair of the vascular complication; the patient died the following day.It is likely that the bleeding and the surgical procedure further compromised the patients hemodynamic state, ultimately leading to death.This fatal event was procedure-related but not device-related as the procedure was aborted with no clip implanted.It appears that the fragile patient condition together with the procedural complication during advancement of the sgc resulted in the perforation of the femoral vein; the hemorrhage was a result of the perforation; hypotension was related to the combination of the bleeding and the surgical procedure.The mitraclip procedure combined with the cascading patient effects listed above contributed to the patients subsequent death.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: 7492859
• MDR Text Key: 107555758
• Report Number: 2024168-2018-03368
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 07/03/2018

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: 08/21/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70821U140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Death