MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

Device Problem Expulsion (2933)

Patient Problems Anemia (1706); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Fatigue (1849); Hypoxia (1918); Nausea (1970); Pleural Effusion (2010); Pulmonary Edema (2020); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 11/02/2021

Event Type  Injury  

Event Description

This report is being filed as the implanted mitraclip detached, requiring surgical removal and another clip procedure.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with mitral regurgitation (mr) grade 4+ and 4.Two mitraclip were implanted without a device issue, reducing the mr to grade 1+, and 1-2.On (b)(6) 2021, the mr had increased to grade 2+/moderate.The clips appeared stable at this time and did not exhibit excessive motion.Worsening heart failure was diagnosed, treated with medications.On (b)(6) 2021, the patient was admitted to a hospital with complaints of dyspnea for 4 days.The patient was transferred to (b)(6) hospital and found to be hypoxic with pleural effusions, placed on a bi-pap machine.On (b)(6) 2021, the patient had generalized abdominal pain, treated with medications.On (b)(6) 2021, another echocardiogram was performed along with an x-ray.P2 flail along with severe mr was noted, along with mitraclip (cds0701-ntw, 10520r172) detachment and migration into the femoral artery.Medication was provided as treatment.On (b)(6) 2021, the patient was admitted to the hospital.The migrated mitraclip was removed via surgical cut down.Tissue was observed in the clip embolized/detached clip.Anther mitraclip was implanted without further issues reported.The mr was reduced to mild immediately after clip release, and then was noted moderate once the systolic blood pressure had raised to 165mmhg.There was no device malfunction reported regarding this clip procedure.Medication was provided for acute on chronic diastolic heart failure.On (b)(6) 2021, the patients hemoglobin and hematocrit were low, treated with 1 unit of packed red blood cells.The electrocardiogram was noted abnormal, without any myocardial infarction.The patients creatinine was slowly trending down (improving) and they were cleared for hospital discharge.No additional information was provided regarding this issue.

Manufacturer Narrative

The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

A4: weight updated.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.The reported patient effects of dyspnea, hypoxia, heart failure, embolism, mitral regurgitation (mr), nausea, tissue damage, and ekg changes are listed in the instructions for use as known possible complications associated with mitraclip procedures.Based on available information, a cause for the reported complete clip detachment could not be determined.The reported embolism, recurrent mitral regurgitation (mr), and tissue damage appear to be cascading events of the complete clip detachment.The reported worsening heart failure appears to be due to a combination of worsening patient condition and the complete clip detachment.The reported fatigue appears to be due to the heart failure.Causes for the reported electrocardiogram (ekg) changes, dyspnea, hypoxia, nausea, and pleural effusion could not be determined.The reported hospitalization, medication, removal of foreign body, surgical intervention, and unexpected medical interventions are the results of case-specific circumstances.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 2020 (pulmonary edema) - removed h6: health effect - clinical code 1706 (anemia) - removed.

Event Description

Subsequent to the previous report, the additional information was received: per chest x-ray on (b)(6) 2021, ¿blunting of bilateral costophrenic angle suggestive of small bilateral effusions.¿ repeat chest x-ray on (b)(6) 2021 showed repeat of pleural effusion, ¿re-demonstration of airspace opacities with bilateral small pleural effusions¿.On (b)(6) 2021, the bleeding, requiring a blood transfusion, and the renal failure, were deemed unrelated to the mitraclip device and unrelated to the mitraclip procedure.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12933812
• MDR Text Key: 284677568
• Report Number: 2024168-2021-11065
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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: 05/23/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10520R172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 89 KG