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

Catalog Number CDS0602-NTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Edema (1820); Cardiac Enzyme Elevation (1838); Mitral Regurgitation (1964); Pulmonary Edema (2020); Heart Failure (2206)

Event Date 04/28/2019

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number (b)(4).

Event Description

This report is filed as the clip detached from one leaflet, while remaining attached to the other leaflet, increased mitral regurgitation and heart failure.Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with non-ischemic functional mitral regurgitation (mr) with dilated cardiomyopathy, primary jet a2p2, and leaflet tethering at the p2.One mitraclip (cds0602-ntr, lot # 81022u343) was implanted without a device issue, reducing the mr to grade 1+.On (b)(6) 2019, the patient starting experiencing a worsening of pre-existing dyspnea and worsening heart failure symptoms.On (b)(6) 2019, per control echocardiogram, the mr worsened to grade 2+ and a mobile postrior medial leaflet was observed.Reportedly, the index procedure mitraclip (cds0602-ntr, lot # 81022u343) had detached from the posterior leaflet, while remaining attached to the anterior leaflet, a single leaflet device attachment (slda ).On (b)(6) 2019, the patient was hospitalized for the worsening dyspnea.Elevated bnp to 10296 pg/ml, pulmonary venous congestion, increasing leg edema with weight gain were observed.Worsening heart failure with worsening cardiac decompensation was diagnosed.Medications were provided.On (b)(6) 2019, another echocardiogram was performed noting severe mr grade 4+ along with severe tricuspid regurgitation.On (b)(6) 2019, another mitraclip procedure was performed as treatment.).Another clip was implanted as treatment.On (b)(6) 2019, the event resolved and the patient was discharged from the hospital.On (b)(6) 2019, a follow-up echocardiogram was performed.The mr was grade 2+ and a mean mitral valve gradient of 6mmhg was noted.No additional information was provided regarding this issue.

Manufacturer Narrative

Exemption number e2019001.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 identified no similar incidents reported for single leaflet device attachment (slda), post procedure, from this lot.The reported patient effects of mitral regurgitation (mr), heart failure, enzyme elevation, cardiac, edema, pulmonary edema as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All the available information was investigated.The reported slda resulting in worsening mr, worsening heart failure, dyspnea, enzyme elevated cardiac, edema, pulmonary edema appears to be related due to patient¿s challenging anatomy and procedural circumstances.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8895370
• MDR Text Key: 154400193
• Report Number: 2024168-2019-10864
• 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: 09/11/2019

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: 10/23/2019
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 81022U343
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 106