MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 01/12/2024

Event Type  Death  

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 4.The patient presented with tortuous venous system.During insertion of the steerable guide catheter (sgc), it became stuck at the level of the right iliac vein.Under fluoroscopy the sgc was seen to be bent slightly.The sgc was pulled back and then could advance with little difficulty.Once the sgc crossed the septum, the patient became hemodynamically unstable.A venogram was performed and bleeding at the iliac vein was observed.The xtw clip was quickly deployed on the valve and the sgc was removed.At this time the vascular team entered and mass transfusion protocol was initiated entailing transfusion along with multiple medications (ivfs, vasopressin, and epinephrine) for blood pressure management.The vein was temporarily tamponaded with a balloon which stabilized the patient for a short period.The patient then began to deteriorate.A code blue was called and the resuscitation measures were taken however, the patient died.In the physician's opinion, the death was due to the sgc perforating the vessel at the level of the iliac vein when it became difficult to advance.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported difficult to advance, associated with the sgc (steerable guide catheter) becoming stuck at the right iliac vein, appears to be related to challenging anatomy with tortuous vein.The reported deformation due to compressive stress, associated with a slight bent on the sgc, appears to be related to the reported difficult to advance as the sgc travelled against resistance.The reported perforation of vessels (iliac vein) was related to the reported difficult to advance.The reported hypotension, hemorrhage, cardiac arrest, and death were cascading effects of the vessel perforation.The reported patient effects of death, vascular perforation, hypotension, hemorrhage, and cardiac arrest, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18639782
• MDR Text Key: 334534265
• Report Number: 2135147-2024-00487
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 31101R1118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG