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

Catalog Number CDS0601-XTR

Device Problem Migration (4003)

Patient Problems Bradycardia (1751); Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Nausea (1970); Pain (1994); Respiratory Distress (2045); Heart Failure (2206)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The mitraclip 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 loose clip and recurrent mitral regurgitation.It was reported that on (b)(6) 2018 the mitraclip procedure was performed in the patient with grade 4 degenerative mitral regurgitation (mr).During the procedure, echo imaging was difficult due to the patient anatomy.It was identified that the clip was not perpendicular to the line of coaptation.The operator tried to re-position the clip but the anterior leaflet could not be released off the gripper.Therefore, the decision was made to implant to clip in this position.Leaflet insertion was assessed with satisfaction.Two mitraclips were implanted reducing the mr grade to 2.On (b)(6) 2018 the patient felt sluggish, nauseous with increased fatigue and hypotension (systolic blood pressure 80's), abdominal discomfort with dry heaving but no vomiting, decreased appetite and poor intake, and shortness of breath (sob) while walking.The patient sleeps for more than 20 hours on two pillows without sob.The transthoracic echocardiogram on (b)(6) 2018 reported that "the grasp of medial clip has become loose results in severe mr that appears to come from medial to medial clip and from between the two clips".The patient requests open surgery to replace the mitral valve.Currently the patient is on the congestive heart failure protocol.The patient also has bilateral pleural effusion, atrial tachycardia/fib and was converted to sinus rhythm with amiodarone.Per the echocardiologist and the operator, both clips are still attached to both leaflets.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed report, additional information was received that the patient expired at the hospital on (b)(6) 2018 before mitral valve surgery could be performed.A mass was found on the abdominal ct scan that was suspected to be metastatic prostate cancer.The patient was in respiratory distress and volume overload on (b)(6) 2018.Bradycardia occurred on (b)(6) 2018 requiring cardiopulmonary resuscitation, but the family decided to discontinue resuscitation.The patient expired.No additional information was provided.

Manufacturer Narrative

Patient codes: 2206 labeled.Internal file number - (b)(4).The device remains in the patient and was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of death, dyspnea, hypotension, mitral regurgitation (mr), nausea, pain, heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Mr was likely a result of the partial clip movement.The other patient effects were cascading effects of the mr or were associated with the patient clinical condition as the patient had metastatic prostate cancer (procedural conditions).A definitive cause for the death in this incident could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.This incident was reviewed by abbott vascular medical affairs and the reviewer stated that: the cause of death was not reported but was likely due to worsening heart failure and was unrelated to the clip.However, it cannot be excluded that recurrent mr may have contributed to the worsening clinical condition.There was no evidence of device malfunction as the potentially suboptimal grasping was likely related to difficult imaging.

• 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: 8226784
• MDR Text Key: 132375960
• Report Number: 2024168-2019-00162
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

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: 07/26/2019
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 80726U177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/09/2019; 03/28/2019
• Supplement Dates FDA Received: 01/29/2019; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER MITRACLIP, STEERABLE GUIDE CATHETER; OTHER MITRACLIP, STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59