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

Catalog Number SGC0302

Device Problem Difficult to Insert (1316)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 03/04/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device 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 perforation resulting in death.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guide catheter (sgc), resistance was felt and the physician thought there was a kink in the guide wire.A second attempt was made to insert the sgc with minus applied and the sgc was able to advance to the left atrium (la) with no issue.When the dilator and guide wire were removed, the patients blood pressure decreased.The sgc was removed and a perforation was noted on the iliac vein.A balloon catheter was used in the attempt to stop the bleeding and then an attempt was made to clamp off the vein however the patient died due to the laceration to the vein.In the physicians opinion, the sgc contributed to the perforation of the vein.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported for difficult to remove the steerable guide catheter (sgc) from this lot.All available information was investigated, and a definitive cause for the reported difficult to insert the sgc into the patient anatomy could not be determined in this incident.The reported perforation appears to be due to operational context (procedural circumstances) and the reported hypotension appears to be the cascading effect of the observed perforation.The reported death appears to be due to procedural circumstances of laceration of the vein.The reported adverse event/patient effect of hypotension, vessel perforation and death as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 8447788
• MDR Text Key: 139687943
• Report Number: 2024168-2019-02273
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81113U219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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