MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0602-XTR

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problems Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Tissue Damage (2104); Ventricular Tachycardia (2132)

Event Date 05/15/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The clip remains in the patient.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 this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted that the patient was in very poor health and had acute coronary syndrome (acs) and severe mitral insufficiencies.There was both prolapse and flail present at p2 and p3.It was determined that this was a last attempt to save the patients life.The first clip delivery system (cds) was advanced to the mitral valve.Grasping was difficult due to the anatomy.Additionally, the gripper arms did not lower and remained raised.It was then observed that the gripper line was visibly broken in the cds handle.Although the gripper arms remained raised, the clip arms were closed and the clip was deployed; however, a rupture occurred on the papillary muscle.A second clip was implanted laterally to secure the first clip.A third clip was implanted medial to the first clip, where the papillary muscle ruptured.It was noted that the patient experienced low blood pressure and ventricular tachycardia (vt); therefore, the procedure was stopped.Three clips were implanted (90305u123, 90211u106, 90301u103) and the mr remained at a grade of 4.Adrenalin was administered for the hypotension and the patient was transferred to the intensive care unit; however, the patient expired.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).It could not be determined which clip contributed to the reported event; therefore, the manufacturing and expiration dates were provided for all three implanted clips: part / lot: cds0602-xtr/90305u123.Date of manufacture: 05-mar-2019.Expiration date: 04-mar-2020.Part / lot: cds0602-xtr/90211u106.Date of manufacture: 12-feb-2019.Expiration date: 12-feb-2020.Part / lot: cds0602-xtr/90301u103.Date of manufacture: 04-mar-2019.Expiration date: 03-mar-2020.The device was not returned for analysis.A review of the lot history records for the implanted clips identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated, and the reported grasping difficulties appears to be related to patient morphology/pathology.The reported gripper actuation issue was a cascading effect of the gripper line break, the broken gripper line was due to the user forcefully pulling on the gripper line to lower the gripper arms that remained raised (user technique).It should be noted that as per the instructions for use (ifu), failure to confirm that both grippers have been lowered onto the leaflets prior to closing the clip may result in loss of leaflet capture and insertion.The tissue damage was a result of the user technique/procedural conditions.The mitral regurgitation (mr), hypotension and ventricular tachycardia were cascading effects/symptoms related to the tissue damage.A definitive cause for the death could not be determined.The reported patient effects of mitral valve tissue damage, hypotension, arrhythmias (ventricular tachycardia), mitral regurgitation(mr) and death are listed in the mitraclip system ifu as known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medial affairs director.The reviewer concluded, death was unrelated to the device and was a complication of the cascade of events resulting from acute coronary syndrome.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8680075
• MDR Text Key: 147371741
• Report Number: 2024168-2019-04514
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2019

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 Catalogue Number: CDS0602-XTR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS.; 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Death
• Patient Age: 80 YR