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

Catalog Number	CDS0201
Health Effect - Clinical Codes	Fatigue (1849); Mitral Regurgitation (1964)
Date of Event	07/12/2017
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 expiration date and date of manufacture are reported as unknown because it could not be confirmed which of two clips experienced the slda; therefore, the information is reported as follows: lot number: 50910u234; date of manufacture: 09/11/2015; expiration date: 09/30/2016.Lot number: 51010u107; date of manufacture: 10/12/2015; expiration date: 10/31/2016.The devices were not returned for analysis.A review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of worsening mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported slda appears to be related to patient morphology/pathology.The reported mr appears to be due to the slda and the fatigue, a cascading effect of the mr.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the devices.
Event or Problem Description
This is filed to report the single leaflet device attachment (slda).It was reported that two mitraclips were implanted on (b)(6) 2016 reducing mitral regurgitation (mr) from grade 4 to 1.On (b)(6) 2017 the patient was unusually tired and went in for a check up.A transthoracic echocardiogram was performed and found a suspected slda and an mr of 4.A transesophageal echocardiogram was performed on (b)(6) 2017 which confirmed the slda and a second mitraclip procedure was performed, implanting two additional clips and reducing the mr to grade 1.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: 6771639
• Report Number: 2024168-2017-06461
• Device Sequence Number: 16454559
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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 Catalogue Number: CDS0201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTHER IMPLANTED CLIP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 42