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); Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem Atrial Perforation (2511)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the difficult removal and clip (80108u208) detachment.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc 80111u124) was advanced into the femoral vein, but resistance was noted.The +/- knob was turned three fourths of a turn to straighten the guide, but the sgc could not be advanced and was removed.It was observed that the sgc tip was not responding in minus direction and a cable break was suspected.A new sgc (80111u127) was advanced successfully.The first clip was implanted, reducing mr to 2.The second clip delivery system (cds 80108u208) was advanced.Visualization and grasping were difficult due to the anatomy.The cds.Was retracted, but became entangled in the chordae.Troubleshooting was performed and the clip was freed.The cds continued to be retracted, but met resistance with the sgc.The cds was pulled hard and a pop was heard.The clip detached from the cds and remained attached to the gripper and lock lines.The clip was caught on the tip of the sgc; therefore, the entire system was retracted together.The clip then caught on the septum.The clip was freed, but the atrial septal defect (asd) was enlarged due to the clip interaction.During removal of the system, resistance was felt with the femoral vein.After removal, it was observed that the sgc soft tip was torn.An asd occluder was used to treat the asd.One clip was implanted, reducing the mr to 2.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported failure to adhere or bond, physical resistance (anatomy), difficulty removing the device from the anatomy and poor image resolution could not be replicated in a testing environment as it was related to patient/procedural conditions.The reported difficulty removing the mitraclip delivery system (cds) from the steerable guide catheter (sgc) could not be tested due to the returned condition of the device.The reported device operates differently than expected (noise) could not be replicated in a testing environment as it was likely a symptom of the observed actuator coupler break.The clip detachment was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined the reported failure to adhere or bond, physical resistance with anatomy and poor image resolution to be due to a combination of patient morphology/pathology and procedural circumstances.The difficult removal of the cds from the sgc due to the clip becoming caught on the guide resulting in noise (device operates differently than expected), detachment of device component (clip detachment) and difficult removal from anatomy appear to be related to operational context of the procedure.The reported patient effect of atrial perforation was related to procedural circumstances of the difficulty removing the clip from the anatomy.It should be noted that the reported patient effect of cardiac perforation (atrial perforation) is listed in the mitraclip nt system instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• 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: 7458360
• MDR Text Key: 106433391
• Report Number: 2024168-2018-03042
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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: 01/09/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80108U208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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, IMPLANTED MITRACLIP(X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 90