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

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 11/29/2017

Event Type  Injury  

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 that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported 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 appears to be related to patient morphology/pathology, while the reported poor image resolution (difficult visualization) was a result of procedural conditions.The reported tissue damage (flailed leaflet) appears to be due to the grasping attempts performed, and therefore a result of procedural conditions; the reported worsening mr was likely a secondary effect of the tissue damage.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the tissue damage and increased mitral regurgitation (mr).It was reported that the mitraclip procedure was performed to treat functional regurgitation (mr) with a grade of 3+.The patient presented with tethering of the posterior leaflet with the mr localized on the medial valve.During grasping attempts on the medial part of the mitral valve, where the jet appeared to be bigger, because of the tethering of the posterior leaflet, grasping was difficult; however, after some failed attempts to grasp leaflets, the decision was made to place the mitraclip more medial than the previous attempt, and in this case the grasping was performed but was unsuccessful.The posterior leaflet was lost during the grasping attempts as visualization of the clip was difficult due to the anatomy and the imaging equipment.The decision was made to invert the mitraclip and pull back into the left atrium.In that moment, it was observed that the mr grade increased to 4+ and a flail was noted on the posterior leaflet (p3) at the location where the grasping attempts were made.The decision was made to end the procedure.No additional information was provided.

• 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7127752
• MDR Text Key: 95171358
• Report Number: 2024168-2017-09842
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70731U222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other