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

Catalog Number CDS0602-NTR

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

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

Event Description

This is being filed to report clip (80115u187) movement.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with an mr grade of 4.The first mitraclip ntr delivery system (80115u187) was advanced to the mitral valve and the clip was positioned close to a pre-existing cleft in the posterior leaflet and the clip was deployed.After clip deployment, a portion of the posterior leaflet came out of the clip, but the clip was still attached to both leaflets.The clip was still stable due to the partially attached posterior leaflet.Mr returned to 4.During preparation of the second clip (80115u128) establishing final arm angle failed several times; the clip would open while locked.The cds was not used and was replaced.A second clip was implanted to stabilize the first clip and to further reduce mr.Mr was reduced to 3.The patient is stable.No additional treatment is planned.No additional information was provided.

Manufacturer Narrative

(b)(4).The mitraclip ntr is currently not commercially available in the us; however, it is similar to a device sold in the us.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 identified no other incidents reported from this lot.Based all available information was investigated and the reported partial clip movement appears to be related to patient morphology/pathology.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP NTR DELIVERY SYSTEM
• 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: 7508218
• MDR Text Key: 108037600
• Report Number: 2024168-2018-03505
• 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: 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: 01/15/2019
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 80115U187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• 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: 01/01/2018
• 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): Required Intervention
• Patient Age: 67 YR