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

Catalog Number	CDS0201
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/05/2017
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 complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the slda could not be determined.The reported patient effect of worsening mr was likely a result of patient/procedural conditions and due to the slda clip.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).It was reported that the initial mitraclip procedure took place on (b)(6) 2015 at the cleveland clinic.Two clips (50526u153 and 50526u152) were placed successfully for treatment of grade 4+ mitral regurgitation (mr).The procedure was performed without any issues noted nd mr was reduced to grade 1+.On (b)(6) 2017 the patient presented to another hospital and was symptomatic.A slda of one of the implanted clips was observed and mr increased to grade 3-4+.There was no leaflet damage noted.No treatment has been performed at this time.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The reported patient effect of worsening mr, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was received: on (b)(6) 2017, the patient underwent another mitraclip procedure for treatment of the single leaflet device attachment (slda) and increased mitral regurgitation (mr).It was determined that it was the second clip (50526u153) that had detached from the posterior leaflet.There was an anterior leaflet prolapse and the mr grade was 4+.In the physicians opinion the slda was due to the patients pre-existing anatomy; 1 clip was placed reducing mr to 1+.This was an excellent outcome for the patient.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: 6970320
• Report Number: 2024168-2017-08402
• Device Sequence Number: 18956986
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/13/2017

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: 05/31/2016
• Device Catalogue Number: CDS0201
• Device Lot Number: 50526U153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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; Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 99