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); Tissue Damage (2104)
Date of Event	06/15/2017
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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Although the mr ultimately remained unchanged as a result of the procedure, the patient effects of worsening mr and mitral valve injury (tissue damage), 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 difficulty grasping and slda appeared to be related to patient morphology/pathology (large anterior leaflet with prolapse and flail).The reported tissue damage was due to the slda and the unchanged mr was due to the tissue damage.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 this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Leaflet assessment revealed the anterior leaflet was large with prolapse and flail noted.There was difficulty grasping the anterior leaflet; however, the clip was able to be deployed onto the leaflets with a good bite on the posterior leaflet.When the lock line was 1/2 way out, a slda was observed with detachment of the clip from the anterior leaflet.A second clip was advanced in an attempt to stabilize the first clip; however, no matter where it was placed, lateral or medial to the first clip, the mr did not change.It was believed that the anterior leaflet had become torn during leaflet detachment; therefore, the decision was made to abort the procedure.Final mr was unchanged at grade 4+.The patient was stable post procedure.There was no clinically significant delay in the procedure reported.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: 6684389
• Report Number: 2024168-2017-05600
• Device Sequence Number: 13463706
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170810(10)60809U229
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2017

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: 08/10/2017
• Device Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Device Lot Number: 60809U229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/03/2017
• 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: STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 104