MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Catalog Number CDS0502

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Unspecified Tissue Injury (4559)

Event Date 03/31/2021

Event Type  Injury  

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 this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leak (air was leaking from the gripper lever).The reported gripper actuation issue (gripper arm could not be fully raised) appears to be due to the troubleshooting maneuvers of the leak.The patient effect of anemia and test result appear to be related to the hypotension.However, a cause for the hypotension and tissue injury cannot be determined.Hypotension, tissue injury, test result and anemia are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported delayed treatment/therapy, unexpected medical intervention, surgical intervention, treatment of medication and hospitalization were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Patient id: (b)(6).This is filed to report leak, gripper actuation, hypotension, medical intervention, prolonged hospitalization, surgical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.On (b)(6) 2021, the first clip was successfully deployed.Then during preparation of the second clip delivery system (cds 00825u102) after the clip established final arm angle/effa, the clip could not open.Troubleshooting was performed and the clip could open, but the clip opened with difficulty.A decision was made to continue using the cds.The cds was advanced to the mitral valve, and the clip was deployed.The procedure continued with a third clip (00825u104).The third cds was advanced to left atrium when a leak was observed.Since the device could not be de-aired, the plastic cover from the gripper line was removed to verify leak.The gripper lever was no longer leaking air; however, the gripper arm could not be fully raised.A decision was made to continue using the third cds.The clip was deployed.However, a tear was observed and the patient's blood pressure dropped abnormally low which resulted in a clinically significant delay in the procedure.The patient remained hospitalized due to the patient's blood pressure was unstable.Three clips were implanted, reducing mr to 3+.The next day, the hemoglobin significantly decreased and medication was administered.The patient became anemic and required a blood transfusion.The patient underwent mitral valve replacement surgery for additional treatment.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 for 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.It should be noted that the mitraclip instruction for use (ifu), warns ¿do not use device if damage is detected.Use of damaged product may result in air embolism, device or device component embolization, vascular and/or cardiac injury¿.Based the reported information, as the user continued to use the device after issues were observed, the use error resulted in the adverse patient effects.The investigation determined the reported leak and subsequent gripper actuation issue appears to be related to a use technique as there was no issues identified during preparation.The failure to follow steps was due to the user deviating from the ifu by continuing to use the device after issues were observed, which led to the reported patient effects and intervention.Based on the information provided, the patient effects were due to the use error of continuing to use the device after damage was observed as it is possible that air was still leaking after the user removed the lever cap and polyimide tubing.The hypotension and subsequent anemia and test result (unstable blood pressure) were a result of reported leak due to the use error.Tissue injury appears to be due to user grasping the leaflets with the gripper actuation issue; therefore, also attributed to the user error.The reported delayed treatment/therapy, unexpected medical intervention, surgical intervention, treatment of medication and hospitalization were results of case-specific circumstances as the patient's blood pressure dropped abnormally low and resulted in a clinically significant delay in the procedure.Hypotension, tissue injury, test result and anemia are listed in the ifu as known possible complications associated with mitraclip procedures.The reported delayed treatment/therapy, unexpected medical intervention, surgical intervention, treatment of medication and hospitalization were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11696428
• MDR Text Key: 246362051
• Report Number: 2024168-2021-03319
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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: 08/25/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00825U104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 68