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); Break (1069); Incomplete Coaptation (2507)

Patient Problems Fever (1858); Mitral Regurgitation (1964); Tachycardia (2095)

Event Date 03/07/2018

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 customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the lock line break and single leaflet device attachment (slda).It was reported this was a mitraclip procedure performed to treat mitral regurgitation (mr) with an mr grade of 4.The anatomy and imaging were challenging; there was difficulty visualizing the clip due to imaging.The clip delivery system (cds) (71207u276) was advanced to the mitral valve, grasping was difficult due to the anatomy.It was difficult to view the leaflets throughout the procedure due to the large left atrium.Only the posterior leaflet was grasped.When unlocking the clip, to re-grasp the leaflet, the lock lever was pulled fast and hard, causing the lock line to break; therefore, there was no way to open the clip.The clip remained implanted on the posterior leaflet only; single leaflet device attachment/slda).Mr remained at 4.A second clip (71207u195) was advanced to stabilize the first clip, however leaflet grasping was unsuccessful due a posterior cleft and tethering of the anterior leaflet.The clip was not implanted and was removed.The patient experienced tachycardia and malignant hyperthermia.Mitral valve replacement was performed.The patient had a good outcome.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 at this time.All available information was investigated and the reported failure to adhere or bond (difficult grasping) appears to be related the challenging patient anatomy (giant pre-existing posterior cleft and a large left atrium).The reported single leaflet device attachment (slda) was related to the procedural circumstances (challenging imaging).The reported lock line break was also a result of procedural circumstances (troubleshooting maneuvers related to the difficulty in grasping the leaflets).The reported poor image resolution is related to the challenging imaging and the difficulties in visualizing the clips during the procedure.The adverse event of fever, tachycardia and unchanged mitral regurgitation (mr) are a result of the procedural circumstances of slda.The reported adverse patient effects of fever, mr, arrhythmias (tachycardia), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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
• 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: 7385247
• MDR Text Key: 103951195
• Report Number: 2024168-2018-02328
• 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: 06/15/2018

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: 12/08/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71207U276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 84