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

Catalog Number CDS0501

Device Problems Knotted (1340); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the lock line issue.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The first mitraclip was ready to be deployed, but during removal of the lock line, after 6 inches were retracted, the lock line became stuck.A knot was suspected after the line became stuck.Several attempts were made to unlock the clip with hopes of removing the first clip, but the attempts were unsuccessful.The first clip delivery system (cds) was removed through the steerable guide catheter (sgc) and then the entire lock line was able to be removed through the sgc.There was no tissue damage/leaflet injury from this issue.The post mr was grade 2.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).Correction: lot number.Evaluation summary: the reported difficult to remove lock line was confirmed as the returned device analysis observed a knotted lock line during analysis of the returned device.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Review of the complaint history did not indicate a lot-specific quality issue.The difficulty removing the lock line appears to be the result of the observed knot.A definitive cause for how the lock line became knotted could not be determined.It is possible that the lock line became knotted during the unwrapping/removal process; however, this cannot be confirmed.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7625552
• MDR Text Key: 112205630
• Report Number: 2024168-2018-04760
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80316U127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 74 YR
• Patient Weight: 46