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

Catalog Number	CDS0201
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 identified no similar incidents reported from this lot.The mitraclip instructions for use instructs the user to raise the grippers, and provides the following caution statement: raising the grippers more often than needed, retracting the gripper lever forcefully, or retracting the gripper lever more than 1.5 cm beyond the mark may damage the gripper cover or impair cds performed.All available information was investigated and the reported gripper line break was likely due to user error, as it was reported that the physician retracted the gripper lever 1-2 cm beyond the blue mark.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 gripper line break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The clip delivery system (cds) was advanced to the mitral valve.When clip deployment was started, it was found that the gripper line was in 2 pieces.It was noted that the gripper lever was pulled beyond the blue line.The cds was removed and replaced without issue.One clip was implanted, reducing the mr to <1.There was no adverse patient sequela or a clinically significant delay in the procedure.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: 6761434
• Report Number: 2024168-2017-06349
• Device Sequence Number: 1967285
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60827U112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 80