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

Catalog Number CDS0602-XTR

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.It is unknown if the clip remains in the patient or if it was implanted.It is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

This is filed to report tissue damage and surgical intervention.It was reported that on (b)(6) 2018, the patient, with grade 4 functional mitral regurgitation, underwent a mitraclip procedure.Three clips were implanted: one clip delivery system (cds) ntr and two cds xtr.During grasping attempts with the third clip, the anterior mitral leaflet tore.Final mr grade was reduced to grade 3.On (b)(6) 2018, the patient was sent for surgical repair.Post-surgical procedure, the patient was in stable condition.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 this event.Additionally, a review of the complaint history did not identify any similar incidents reported from this lot.The reported patient effects of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported failure to adhere or bond could not be determined.The reported tissue damage appears to be due to user technique/procedural circumstances as it was reported that maneuvering of the device resulted in the mitral valve injury.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR 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: 7607322
• MDR Text Key: 111268082
• Report Number: 2024168-2018-04513
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/14/2018

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: 01/12/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80112U184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/14/2018
• 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: 2 IMPLANTED CLIPS, STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR