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

Catalog Number CDS0601-XTR

Device Problems Unintended Movement (3026); Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the sleeve steering issue.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3+.The clip delivery system (cds) was inserted with the blue alignment markers aligned, and advanced to the left atrium; however, when turning the m-knob, the cds steered in the wrong direction.This occurred on two separate occasions and it was suspected that the blue line on the cds was not correct.The clip was not implanted and the cds was removed and replaced.A new cds was used to complete the procedure.One clip was implanted reducing mr to 1+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: all available information was investigated.The reported sleeve steering issue and device misassembled during manufacturing or shipping could not be confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incident reported from this lot.In the absence of a confirmed failure mode a conclusive cause for reported difficult to position/sleeve steering issue and device misassembled during manufacturing or shipping issue could not be determined.The observed corrosion on the actuator coupler appears to be due to a consequence of exposure to residual saline solution to the device post procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8650518
• MDR Text Key: 146387806
• Report Number: 2024168-2019-04173
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 81226U176
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Age: 91 YR