MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional mitraclip device is filed under a separate medwatch report number.

Event Description

This is filed to report the white spots observed coming out of the gripper or lock line lumen.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr).The first clip was successfully deployed.Then during preparation of a second clip delivery system (cds 00129u124), it was observed that the grippers were not lowering simultaneously.Troubleshooting was performed, but both grippers were still not lowering.The cds was not used in the patient, and a new cds was prepared to continue with the procedure.However, during preparation of the third cds (00116u117), the cds was de-airing when small white spots were observed coming out of the gripper or lock line lumen.The cds was not used in the patient, and another cds was used to successfully complete the procedure.Two clips were implanted, reducing tr.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other incident reported from this lot.All available information was investigated and a definitive cause for the reported device contamination with other material or chemical could not be determined in this incident.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9990690
• MDR Text Key: 189068610
• Report Number: 2024168-2020-03853
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

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: 01/16/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00116U117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1