MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Model Number	CDS0201
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Heart Failure (2206)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified 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 quality issue.The reported patient effects of worsening mitral regurgitation and worsening heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and the reported slda appears to be related to the patient morphology/pathology due to posterior leaflet prolapse.The reported mr was likely a result of the slda, which then caused the cascading effect of heart failure.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
Event or Problem Description
This is filed to report the single leaflet device attachment (slda) resulting in increased mitral regurgitation and heart failure.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017, to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to 1.The next day, discharge echocardiogram confirmed the clip was stable, and the mr was 1.On (b)(6) 2017, the patient was admitted to the hospital with heart failure.Echocardiogram was performed which found that the deployed clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).The mr had increased to 4.There was no tissue damage noted.The patient remains stable and will be considered for an additional procedure at a later date.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Filed to report the attempted intervention.
Event or Problem Description
Subsequent to the initial 30-day medical device report, the following information was provided: on (b)(6) 2017, the patient presented to the emergency room with heart failure symptoms.On (b)(6) 2017, a second mitraclip procedure was going to be performed for treatment; however, during the transseptal puncture, a pericardial effusion occurred.No portion of the mitraclip system had entered the patient anatomy.It is the physicians opinion that the non-abbott guide wire in the left atrium caused the effusion.A pericardiocentesis was performed, but the patient expired.The cause of death was cardiac arrested due to the pericardial effusion which was caused by the transseptal puncture.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6474394
• Report Number: 2024168-2017-02950
• Device Sequence Number: 608731
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170630(10)60607U141
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Device Lot Number: 60607U141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 52