MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip delivery system was discarded and the clip remains in the patient.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 clip opening slightly after clip deployment and the mitral stenosis.It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr) in the patient with calcified, thick leaflets and a small atrium.The leaflets were grasped and the mr was reduced to grade 2 to 3.After clip deployment, the clip appeared to have opened slightly, 20 to 30 degrees.Both leaflets are in the clip, but the clip moved a little from its original location and was not as stable as desired.The clip opening slightly impacted the mr reduction.Mr grade was grade 3.It is suspected that the clip opened slightly because of the calcified, thick leaflets.A second mitraclip was not considered due to the mean mitral valve pressure gradient of 9 mm hg with one mitraclip.There were no adverse effects due to the increase in pressure gradient.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 that would have contributed to this event.Review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of mitral stenosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported partial clip movement (failure to adhere or bond) and mechanical issue (clip open while locked) appears to be related to patient morphology/pathology due to the calcified, thick leaflets and a small atrium.A definitive cause for the reported mitral stenosis cannot be determined as it could be related to patient or procedural conditions.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: 7276974
• MDR Text Key: 100275038
• Report Number: 2024168-2018-01176
• 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: 04/25/2018

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: 10/24/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71023U140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 04/25/2018
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other