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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip remains in the patient and the delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The steerable guide catheter and additional cds referenced are filed under separate medwatch reports.

Event Description

This is filed to report the difficult to remove the clip delivery system (cds 70713u173) with a previously implanted mitral valve ring.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with an mr grade of 4.Imaging was difficult due to the rotated heart.The steerable guide catheter (sgc) and the cds (70713u170) were advanced to the mitral valve.When applying m knob, the cds moved in the p direction.When applied again, the cds had normal movement.The puncture height was too low and the decision was made to remove the system and perform a higher puncture.During removal of the cds, the clip was caught in the chordae and also became caught on the tip of the sgc.Troubleshooting was performed and the clip was freed; however, a chordae rupture occurred and the mr increased from to 4+.The clip was able to be retracted into the sgc, but after removal, chordae tissue was noted on the clip and the sgc tip was torn.A second transseptal puncture was performed, and a new sgc and new cds (70713u169) were advanced.The clip was implanted successfully in a2p2; however, a second jet was created due to chordal rupture.Another clip (70713u173) was advanced, but due the position of the jet, there was difficulty positioning the clip making grasping impossible.The clip then got caught in a previously implanted mitral valve ring.The clip was freed and then deployed successfully.Two clips were implanted, reducing the mr to 3-4.The procedure was extended 2 hours due the chordae rupture and second transseptal puncture.No additional information was provided.

Manufacturer Narrative

(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 that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported difficulty grasping and difficulty removing the device appears to be related to procedural conditions due to the reported physical resistance and poor image resolution.The reported poor resolution appears to be related to the rotated heart; therefore, attributed to patient morphology/pathology.Additionally, the reported physical resistance also appears to be related to patient morphology/pathology due to the position of the jet.There is no indication of a 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: 7271627
• MDR Text Key: 100281176
• Report Number: 2024168-2018-01116
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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: 07/13/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70713U173
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP
• Patient Age: 58 YR