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

Catalog Number CDS0601-XTR

Device Problems Break (1069); Entrapment of Device (1212); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Renal Failure (2041); Shock (2072)

Event Date 03/28/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.User facility medwatch report (b)(4) received on 04/14/2019.Patient presented to the operating room on (b)(6) 2019 for a mitraclip insertion.The clip was deployed.As per protocol the lock was tested under fluoroscopy.The lock failed, and the clip arms opened.Multiple attempts to reclose the device were unsuccessful.The mitraclip was unable to safely be removed from the patient, therefore the delivery system was anchored to the groin with a tegaderm and the patient required emergent redo sternotomy for mitral valve surgery and removal of mitraclip.The patient required an iabp and ecmo and was transported to nurse unit for post op care.He subsequently developed bleeding, shock, aki and left lower extremity ischemia.When it was determined there were no further effective treatments to offer the patient, support was withdrawn per family wishes and the patient expired on (b)(6) 2019.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.(b)(4).

Event Description

This is filed to report the patient death.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During preparation of the mitraclip delivery system (cds) the gripper lever cap was over rotated in the open direction and the cap came off.The cap was placed back on the device and the cds was continued to be used.The cds was advanced to the mitral valve and grasping was performed.An attempt was made to establish final arm angle (faa), but the clip jumped open to 120 degrees.An attempt was made to reclose the clip, but it would not close past 120 degrees.The grippers were raised to release the leaflets, and the clip was retracted to the left atrium (la).Additional troubleshooting attempts were made to close the clip but were unsuccessful.Slack was noted in the lock line; therefore, hemostats were used to apply tension on the lock line, but the lock line broke and one end was pulled into the cds.The clip could not be closed and the cds could not be removed; therefore, the patient was sent to sternotomy surgery to remove the device, and mitral valve replacement surgery.The patient required an intra-aortic balloon pump (iabp) and extracorporeal membrane oxygenation (ecmo), and was transported to a nurse unit for post op care.The patient subsequently developed bleeding, shock, acute kidney injury and left lower extremity ischemia.No further treatment was performed and the patient expired on (b)(6) 2019.Per the physician, the mitraclip did cause and contributed to the patient death.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Subsequent to the previously filed report, the following information is being provided: abbott submitted medwatch # 2024168-2019-03206 on (b)(6) 2019 with notification of the voluntary recall in h7, (remedial action initiated) for events related to unexpected clip opening.Abbott recently received eleven reports of xtr clips unexpectedly opening and becoming nonfunctional resulting from unintended excessive force applied to the clip during implantation.Once the clip becomes nonfunctional, the inability to close and remove the device has led to surgery or additional intervention.This event is one of the eleven.To prevent unintended excessive force from being applied to the clip, abbott developed revised instructions for performing the steps establish final arm angle and invert the clip arms.The field safety notification (fsn) includes these revised instructions.Abbott will train all mitraclip implanters on the revised instructions.

Manufacturer Narrative

Internal file number - (b)(6).Evaluation summary: based on the information reviewed and the overall evaluation of the returned device, a definitive cause for the reported mechanical issue could not be determined.It is possible that while establishing final arm angle (faa), the user could have caused unintentional excess force to be placed on the clip, which can result in the reported issue; however, this cannot be determined in this incident.The hinge pins were observed to be disengaged during returned device analysis.The reported entrapment of device or device component and mechanical jam appears to be due to the observed hinge pin detachment.The reported lock line break was likely due to procedural circumstances as hemostats were used to apply tension on the device.A definitive cause for the reported lock line slack could not be determined in this incident.The reported clip jumpiness was likely a cascading effect of lock line slack that can create excessive tension on the clip components and result in inappropriate clip actuation.A definitive cause could not be determined for the reported hemorrhage, shock, renal failure (kidney injury) and ischemia.The adverse event of foreign body is a result of case specific circumstances.This event was reviewed by an abbott vascular medial affairs director and the reviewer stated that in this case the death was unrelated to the device and was a consequence of the surgical intervention that was decided after the mitraclip procedure failed.The reported patient effects of death, hemorrhage, peripheral ischemia, renal failure and shock are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.The observed material deformation (connector), bent harness, actuator coupler break and scratches on the l-lock tabs are due to procedural circumstances as multiple troubleshooting attempts were performed to close the clip and retract it out of the patient anatomy.The observed loose or intermittent connect of steerable sleeve handle is likely a result of post procedural handling of the device.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 lot specific product issue.Due to an observed hinge pins disengagement during returned device analysis, a potential product issue was confirmed.Engineering investigation to date has determined that unintended excessive force applied to the clip can cause hinge pin disengagement in the mitraclip xtr design.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The fda z number has not yet been provided to the manufacture.Abbott vascular made the decision to initiate a voluntary field action for the mitraclip xtr clip delivery system, april 18th 2019, recall file under medwatch # 2024168-2019-03206.

• 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: 8529838
• MDR Text Key: 142457111
• Report Number: 2024168-2019-03094
• 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,health
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2019
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 81203U176
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 81