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

Model Number CDS0701-NT

Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Unintended Movement (3026)

Patient Problems Angina (1710); Cardiac Arrest (1762); Dyspnea (1816); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Shock (2072); Tachycardia (2095)

Event Date 08/25/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

This is filed for a clip opening while locked and a patient death.It was reported that on (b)(6) 2022, a patient presented with grade 4 degenerative mitral regurgitation (mr), rotated heart, and suboptimal transseptal puncture.During a mitraclip procedure, there were difficulties with imaging and positioning the device due to the anatomy.A low transseptal puncture resulted in difficulties gaining height above the mitral valve, but was ultimately successful for all three clips implanted during the procedure.The first ntw mitraclip (20509r147, cds0701-ntw) was implanted successfully.After the deployment of a second mitraclip, an nt (20324r138, cds0701-nt), was detached from the clip delivery system (cds), the clip opened while locked to approximately 110 degrees.The nt clip detached from the posterior leaflet, resulting in a single leaflet device attachment (slda).An additional nt mitraclip (20420r141, cds0701-nt) was implanted to stabilize the slda.Second establishing final arm angle (efaa) was not performed with the third nt clip.The mr was reduced to grade 2.The patient was stable.On (b)(6) 2022, a hemothorax occurred and the patient expired.The cause of the hemothorax is unknown.No additional information was provided.

Manufacturer Narrative

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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and without the device to analyze, a cause for the unintended movement of clip opening while locked (cowl) could not be determined.Slda however, appears to be due to the clip opening while locked after deployment.Difficult or delayed positioning associated with positioning the device in the anatomy appears to be related to patient morphology/pathology (low transseptal puncture).Image resolution poor was related to patient and procedural conditions as difficulty with imaging was reported due to the anatomy.The improper or incorrect procedure or method is associated with the user not performing the second establish final arm angle (efaa) testing after lock line removal prior to clip deployment.A cause for the hematoma (hemothorax) cannot be determined.Angina, dyspnea, hypotension, hypoxia, tachycardia, shock and cardiac arrest, however, are symptoms of the hematoma.Additionally, death appears to be due to hemothorax and associated hypotension and shock.Hematoma, angina, dyspnea, hypotension, tachycardia, shock and cardiac arrest and death are known possible complications associated with mitraclip procedures.The unexpected medical interventions and medication required were a result of case-specific circumstances.His event was further reviewed by abbott medical affairs senior director (md).The reviewer stated "in reviewing this case, the patient underwent teer for degenerative mr.The patient¿s heart was rotated and trans-septal puncture was challenging; the trans-septal puncture was low @ approximately 3.5 cm.The first clip was an ntw and was successfully implanted; a second clip was then deployed to further reduce mr, this was an nt.Upon releasing the clip, a cowl event occurred with the clip opening to 110 degrees with associated slda (remained attached to amvl).A third clip was implanted to stabilize the slda and final mr was 2+.Of note, the second efaa was not performed for the second or third clip.Two hours post procedure the patient developed chest pain, sob and hypotension and eventual shock requiring pressor support.The following day, a hemothorax was diagnosed.A chest tube was placed.Additionally, the patient required transfusion with plasma, platelets and prbc.An echo showed the all three clips were identified on the valve.There in nothing to indicated the mr had worsened.The patient eventually expired.The death was not due directly to the mitraclip devices.While there was an cowl and associated slda event, it was dealt with appropriately with deployment of an additional clip to stabilize the slda.The clips were stable on repeat echo.The hemothorax possibly occurred due to cardiac or vascular injury during catheter manipulations in the patient with challenging anatomy, in particular a rotated heart.A hemothorax would not primarily be caused by either a cowl event or an slda.The hemothorax and associated hypotension and shock appear to be the cause of the patient¿s death per records provided.¿ (reference pre-investigation task medical review within the complaint record).Lastly, this event and the imaging provided by the account were further reviewed by an abbott senior staff clinical engineer.The reviewer noted that ¿four (4) fluoroscopic videos and twenty-two (22) echocardiographic videos were provided.The first fluoro video was taken post deployment of the first clip (no reported issue) in which the deployed clip can be visualized on the valve and the cds is actively being retracted into the sgc.The second video was taken during deployment of the second clip (reported device).Specifically, the video was taken during deployment steps to detach the clip from the cds, in which the delivery catheter (dc) shaft can be seen being detached from the clip and retracted against the steerable sleeve soft tip.The clip appears to be partially attached to the l-lock as the dc is retracted, with full detachment apparent when the clip releases in a sudden movement.The clip arms appear to be open to ~120° in the video.While this is an estimation based on visual assessment with the naked eye and cannot be confirmed, it is apparent that the clip arms are opened to a noticeably large degree beyond the fully closed position and aligns with the reported incident details.It is unclear during which step, specifically, the clip arms opened (e.G.1st efaa check, lock line removal, etc.).The third and fourth fluoro videos were taken post deployment of the third clip (no reported issue); in these videos the reported clip remains stable in between the two other clips and opened at ~120°.All 22 echo videos were reviewed.Many of the videos were blurry and hard to discern the view type and if clip(s) were present.Several 4-chamber views show an artifact at the valve plane which is presumably one of the implanted clips.No additional information can be obtained from the echo videos.¿ the device is included in the correction notice issued by abbott on 06 sep 2022 for clips not being able to establish final arm angle (efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).

Event Description

It was reported that on (b)(6) 2022, a patient presented with grade 4 degenerative mitral regurgitation (mr), rotated heart, and suboptimal transseptal puncture.During a mitraclip procedure, there were difficulties with imaging and positioning the device due to the anatomy.A low transseptal puncture resulted in difficulties gaining height above the mitral valve, but was ultimately successful for all three clips implanted during the procedure.The first ntw mitraclip ((b)(6)) was implanted successfully.A second mitraclip, an nt ((b)(6)), was deployed.After detachment from the clip delivery system (cds), the nt clip opened while locked to approximately 110 degrees.The nt clip detached from the posterior leaflet, resulting in a single leaflet device attachment (slda).An additional nt mitraclip ((b)(6)) was implanted to stabilize the slda.Second establishing final arm angle (efaa) was not performed with the third nt clip.The mr was reduced to grade 2.The patient was stable.On (b)(6) 2022, a hemothorax occurred and the patient expired.The cause of the hemothorax is unknown.10/6/2022: subsequent to the initial mdr: during the procedure second efaa was not performed on the 2nd/slda clip ((b)(6)) and the 3rd clip ((b)(6)).On (b)(6) 2022, two hours periprocedural, a surface echocardiogram was performed as the patient experienced chest pain, shortness of breath, and was hypotensive.The clips were stable on the leaflets.The 1st and 3rd clips were attached to both leaflets.The 2nd clip was attached to anterior and detached from the posterior.On (b)(6) 2022, a hemothorax occurred.Adverse patient effects such as hypotension, hypoxia, tachycardia, and shock occurred.Chest tube thoracostomy was performed to treat the hemothorax.Additional treatments and medications were administered such as a blood transfusion, platelet and plasma transfusion, intubation, arterial line, levophed drip with vasopressin, epinephrine drip, and two rounds of advanced cardiovascular life support (acls).In the physician's opinion, the mitraclip procedure contributed to the hemothorax.The exact cause of the hemothorax was unknown.It was noted that the patient expired at 3:30 am on (b)(6)2022.The transthoracic echocardiogram (tte) displayed stable mitraclips that were attached to the leaflets, with the exception of the anterior leaflet from the slda.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15447090
• MDR Text Key: 300157061
• Report Number: 2135147-2022-01241
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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: 03/23/2023
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20324R138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG