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 Death (1802); Pericardial Effusion (3271)

Event Date 04/25/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other two clip delivery systems are filed under separate medwatch report numbers.

Event Description

This is filed to report the pericardial effusion that was noted during use of the second device from the second procedure and to report the patient death.It was reported that on (b)(6) 2018 two mitraclips were implanted reducing the degenerative mitral regurgitation from grade 4 to grade 2.The following day, on (b)(6) 2018, the first mitraclip was noted to have a single leaflet device attachment (slda) and mr increased to grade 3 to 4.The clip had detached from the anterior leaflet.Another mitraclip procedure was performed to stabilize the slda clip.A third mitraclip was implanted between the first two mitraclips but after clip deployment, this mitraclip also had an slda.This clip also detached from the anterior leaflet.The physician believes the friable anterior leaflet was the cause of the slda.A fourth clip delivery system was inserted to stabilize the third mitraclip but there was difficulty grasping the leaflets.A pericardial effusion was noted during this case and the procedure was aborted.No treatment was given for the effusion.The patient expired on (b)(6) 2018 from multiple organ failure.In the physician's opinion, the mitraclip did not cause or contribute to the death because the patient died from pre-existing multiple organ failure.There was no additional information 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.Review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of death and pericardial effusion as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported failure to bond (difficulty grasping the leaflets) appears to be related to the challenging patient morphology/pathology (friable anterior leaflet).The reported pericardial effusion appears to be related to procedural circumstances (trigger of the fatal cascade of events combined with maneuvers of grasping attempts) and death is a combination of the pericardial effusion and the pre-existing organ failure.This event was further reviewed by an abbott vascular medical affairs director.The reviewer concluded that in this case, the procedure was conducted in a patient with challenging anatomy: according to the operator, the anterior leaflet was friable, which caused repeated clip detachment during the several attempted implantations in the 2 successive procedures performed.A pericardial effusion was noted during the redo procedure leading to procedure abortion and death 2 days after in a context of multi-organ failure.Death was not related to the device, but to the procedure and the trigger of the fatal cascade of events was the pericardial effusion, leading to hemodynamic compromise, then to multi-organ failure.There is no information to help understand the possible cause of pericardial bleeding.A potential common cause observed in other procedures is atrial wall perforation caused by the transseptal puncture.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: 7524612
• MDR Text Key: 108610746
• Report Number: 2024168-2018-03700
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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: 11/03/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71102U166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: 92 YR
• Patient Weight: 54