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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 05/29/2018

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 filed to report the flail noted to the leaflet after the grasping attempt.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were successfully implanted; however, grasping was noted to be difficult with both clips due to imaging.A third clip delivery system (cds) was advanced to the mitral valve to treat the remaining moderate mr.Grasping was noted to be difficult again due to imaging.After the second grasp attempt, a flail was suspected and the leaflet appeared to be degraded.The procedure was discontinued and the third clip was not implanted.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (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 difficulty grasping the leaflets appears to be a combination of patient morphology/pathology (prolapse)and the procedural circumstances (visualization).The reported poor image resolution is related to the imaging issues, difficulties in visualizing the clip during the procedure.The reported tissue damage appears to be related to procedural circumstances of difficulty grasping.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: 7614428
• MDR Text Key: 111523028
• Report Number: 2024168-2018-04604
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: 03/01/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80228U239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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, IMPLANTED CLIPS (2)
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 64