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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

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

Event Date 04/11/2018

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 additional relevant information.The other clip delivery system is being filed under a separate medwatch report.

Event Description

This is filed to report the resistance with the anatomy during removal.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first clip delivery system ((b)(4) was advanced to the mitral valve.The deployment sequence was started; however, the clip was difficult to deploy due to the patient anatomy and the posterior torque applied to the device.Troubleshooting was performed and the clip was able to be deployed.A second clip ((b)(4)) was deployed without issue and the mr was reduced to 2.The third cds ((b)(4)) was advanced to the mitral valve; however, grasping was difficult.The cds was retracted and the clip became caught in the chordae.The clip was able to be retracted, but chordal and leaflet damage was noted.The mr returned to 4.The procedure was discontinued.On (b)(6) 2018, the patient was brought back in an attempt to further treat the mr.The cds ((b)(4)) was advanced for extreme lateral placement to anchor another device; however, grasping was difficult.The cds was removed.A non-abbott 30mm cardio form device was placed in the lateral orifice and the mr was reduced to 1+.The patient was stable.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 indicate a lot-specific quality issue.All available information was investigated and the reported difficulty grasping appears to be related to patient morphology/pathology (low transseptal puncture).A definitive cause for the clip becoming caught in the chordae could not be determined.The reported tissue damaged appears to be results of the clip becoming caught in the chordae and the unchanged mitral regurgitation (mr) was due to the clip was not implanted.The reported patient effects of mitral valve injury (tissue damage) and mr, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.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: 7477292
• MDR Text Key: 107038267
• Report Number: 2024168-2018-03191
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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: 01/04/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80103U261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No
• 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 CATHETER2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 76