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

Catalog Number SGC0301

Device Problems Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Atrial Perforation (2511); Pericardial Effusion (3271)

Event Date 07/16/2018

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 steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system referenced is being filed under a separate medwatch report.

Event Description

This is filed to report the irregular movement with the steerable guide catheter (sgc) and death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The sgc and clip delivery system (cds) were advanced into the anatomy.While steering the cds with the m-knob, negative was removed from the sgc, which caused the sgc to bend.Due to image quality, the cds tip could not be seen on echocardiogram.The patients pressure dropped and a pericardial effusion was noted in the left upper pulmonary vein, which resulted in tamponade and cardiac arrest.In the physicians opinion, the perforation was due to the sgc bend while steering the cds without visualization.The patient was sent for open surgery, placed on a bypass machine, and the chest was closed.The patient was on a balloon pump in stable condition in the intensive care unit (icu); however, the patient passed away the same day.The cause of death was reported to be refractory right ventricular (rv) failure and coagulopathy following emergent redo sternotomy for repair of the pulmonary artery perforation.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported bent steerable guide catheter (sgc) appears to be primarily related to user technique/procedural circumstances, with patient morphology/pathology also maybe contributing to it.The poor image resolution was associated with the image quality being sub-optimal.The perforation was caused by the clip, and was due to advancing the clip delivery system (cds) while the sgc was bent.The bent sgc along with steering/advancing the cds without visualization, resulted in the perforation of the left upper pulmonary vein.The reported perforation then caused the cascading effects of pericardial effusion, hypotension, cardiac tamponade and cardiac arrest.The cause of death was reported to be refractory right ventricular (rv) failure and coagulopathy following the surgery.The reported patient effects of cardiac perforation, cardiac arrest, death, hypotension, cardiac tamponade and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.This event was further reviewed by an abbott vascular medical affairs director and the reviewer stated that in this case, due to image quality, the cds tip could not be seen on echocardiogram.Death was not directly related to the device, but the procedure initiated a cascade of events necessitating surgical intervention.

Event Description

Subsequent to the previously filed information, the following additional information was provided: after the clip delivery system (cds) was advanced into the anatomy through the steerable guide catheter (sgc), the clip was not seen exiting the sgc due to the image quality.Negative was applied to the sgc and m-knob was applied to the cds.It was then observed that the sgc was in the left upper pulmonary vein.The use of the knobs while the device was in the vein caused a bend in the sgc.The clip was still not visualized.The cds was advanced further; however, the patients pressure dropped and a pericardial effusion was noted in the left upper pulmonary vein, which resulted in tamponade and cardiac arrest.In the physicians opinion, the perforation was caused by the clip, and was due to advancing the cds while the sgc was bent.Surgery was performed on the table after the clip was removed.No additional information was provided.

• 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: 7768209
• MDR Text Key: 116600328
• Report Number: 2024168-2018-06133
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80226U155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 68