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

Catalog Number CDS0602-XTR

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Thrombosis (2100)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the filament attached to the tip of the clip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3-4.The clip delivery system (cds) was advanced to the mitral valve.After straddling, the m-knob was applied; however, a filament was observed attached to the tip of the clip.It could not be determined if this was a fiber or a clot.The activated coagulation time (act) was 250 at the time.The clip was not implanted, and the cds was removed and replaced.Once outside of the anatomy, the cds was inspected and the filament was still attached to the tip of the clip; however, it could not be determined if it was thrombus or fiber.One clip was implanted, reducing mr to 1-2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: all available information was investigated, and the reported issue could not be confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.In the absence of a confirmed failure mode of foreign material present on device, a conclusive cause could not be determined.A definitive cause for the reported thrombus could not be determined.The reported patient effect of thrombus is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.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
• MDR Report Key: 8479071
• MDR Text Key: 140790709
• Report Number: 2024168-2019-02587
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 81228U106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other