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); Incomplete Coaptation (2507); Mechanical Jam (2983)

Patient Problems Death (1802); Tissue Damage (2104)

Event Date 02/13/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The customer reported the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other two mitraclips (70828u115, 70905u163) are filed under separate medwatch report numbers.

Event Description

This is filed to report the complete clip detachment with clip delivery system (cds 71027u246).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first cds (70828u115) was advanced to the left atrium; however, while dropping the grippers, there were more micro bubbles present than expected.The cds was removed and replaced.The next cds (70905u163) was advanced to the mitral valve and the clip was deployed.The final cds (71027u246) was advanced to the mitral valve.Grasping was performed.While establishing gripper line removability, it was note that the gripper line felt tight.Deployment was continued.After 6 inches of the gripper line was removed, it was observed that the clip changed orientation on the valve.It was then found that the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda) and a new flail was present.The gripper line continued to be removed; however, the clip detached from the anterior leaflet (complete clip detachment/ccd).The cds was pulled into the guide, and the clip was retracted with the gripper line, but could not be retracted into the mouth of the guide.The system was retracted to the right atrium.The first implanted clip then detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr returned to 4.The devices were left in the anatomy and the patient was sent to mitral valve replacement surgery.On (b)(6) 2018, the patient died.No additional information was provided.

Manufacturer Narrative

(b)(4).Internal file number - (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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of tissue damage and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medical affairs director who concluded that the death was likely a complication of surgery and was not directly related to the device.The mitraclip nt instructions for use (ifu) states: if excessive resistance is noted at both ends of the gripper line (resulting in failure to establish gripper line removability (eglr)), stop and remove the clip delivery system.As the clip was deployed despite an unsuccessful eglr test, the use deviation contributed to the partial clip movement, single leaflet device attachment (slda) and subsequent complete clip detachment (ccd).All available information was investigated and the partial clip movement, slda and ccd appear to be a result of patient morphology/pathology and with the user continuing to deploy the clip and attempting to remove the gripper line when eglr was not performed successfully.A definitive cause for the reported difficulty to remove the gripper line could not be determined.The procedural conditions of ccd resulted in the clip unable to be retracted into the guide and thus the cds was difficult to remove from the sgc.The reported tissue damage appears to be due to the slda.A definitive cause for the reported death however, could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing 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: 7325920
• MDR Text Key: 101950314
• Report Number: 2024168-2018-01684
• 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: 05/29/2018

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: 10/28/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71027U246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 37