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); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 12/28/2017

Event Type  Death  

Manufacturer Narrative

The patient and device codes were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the possible clip movement, possible tissue damage and patient death.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with an mr grade of 4.The first clip was implanted reducing mr to 2-3.To further reduce mr, a second clip was implanted successfully; however, mr returned to 4.It was suspected there was either clip movement or tissue damage from the first implanted clip.A third clip was advanced and grasping was performed; however, the clip was not implanted because there was no further reduction in mr.Mr remained at 4.The next day, on (b)(6) 2017, the patient died from right heart disease, severe mr and severe left ventricular ejection fraction.An autopsy was not performed.It was the physicians opinion, that the mitraclip or mitraclip procedure caused or contributed to the death, due to the remaining severe mr.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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported partial clip movement appears to be related to patient morphology/ pathology (chordal rupture, prolapse/flail of posterior mitral leaflet, fragile leaflets).The reported tissue damage appears to be related to procedural circumstances of partial clip movement.The unchanged mitral regurgitation (mr) was likely a cascading effect of the tissue damage.A definitive cause for the right-side heart disease (heart failure) cannot be determined.Death was reported to be due to the procedural circumstances and patient conditions including mr, heart failure and severe lvef.It should be noted that while the mr ultimately remained unchanged, the reported patient effects of worsening mitral regurgitation, worsening heart failure, mitral valve injury and death are listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.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: 7210558
• MDR Text Key: 97922955
• Report Number: 2024168-2018-00514
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71018U167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/11/2018
• 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
• Treatment: OTHER IMPLANTED CLIPSTEERABLE GUIDE CATHETER
• Patient Outcome(s): Death