MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Perforation (2001); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/14/2021

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.Based on available information, the cause of reported heart failure was due to atrial perforation.The cause of atrial perforation could not be determined.The cause of reported hypoxia and renal failure could not be determined.The reported patient effects of heart failure, atrial septal defect, respiratory dysfunction and renal failure are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report after the procedure, the patient experienced respiratory distress, heart failure, atrial perforation and renal failure.It was reported that the mitraclip procedure was performed on (b)(6) 2019 to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr to 1.On (b)(6) 2021, the patient had a follow-up and was experiencing respiratory distress.A computerized tomography (ct) scan showed congestion and enlargement of the heart.There was no deterioration [increase] of mr confirmed, the clip remained stable on both leaflets and no tissue damage was noted, but a left to right shunt was confirmed on echocardiography.An increase in brain natriuretic peptide (bnp) level and deterioration of renal function was also observed.Since iatrogenic atrial septal defect is the cause of exacerbation of heart failure, the patient is scheduled for surgery at a later date.No additional information was provided.

Event Description

Subsequent to the initial report filing, additional information was received reporting that the patient had was treated with a septal occluder on (b)(6) 2021.The patient condition was resolved and discharged without symptom.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 this event.Based on available information, the cause of reported heart failure was due to atrial perforation.The cause of atrial perforation could not be determined.The cause of reported hypoxia and renal failure could not be determined.The reported patient effects of heart failure, atrial septal defect, respiratory dysfunction and renal failure are listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12590625
• MDR Text Key: 275183953
• Report Number: 2024168-2021-08988
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90502U110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 52