MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0301

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional cds is being filed under a separate medwatch report.

Event Description

This is filed to report thrombus clot.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.One clip was implanted, reducing the mr to 1.A small clot was then observed attached to the steerable guide catheter (sgc).As the sgc was being moved to the right atrium, the clot detached and disappeared.An increased dose of anticoagulation was administered.A clip delivery system (cds) was advanced to treat the tricuspid valve with a tr of 4.The cds was advanced out of the sgc before proper visualization was obtained and the clip went into the septum and became stuck.After careful manipulation, the cds was able to be retracted back into the right atrium.The clip was deployed on the tricuspid valve, reducing the tr to 1.A large atrial septal defect was noted in the septum which was closed with an amplatzer device.No additional information was provided.

Manufacturer Narrative

Device codes: 2993 labeled na.Internal file number - (b)(4).Correction: device code 1494 removed.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The definitive cause for thrombosis could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8316997
• MDR Text Key: 135416277
• Report Number: 2024168-2019-00933
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 81113U136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 99 YR
• Patient Weight: 59