MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0501

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

Patient Problem Thrombosis (2100)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the foreign material and clots.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 into the patient anatomy when an object was noted on the clip arms and thrombus was suspected.The cds was removed and it was noted the clip arms were entangled with a silk like object with some clots.The object was rinsed and the physician tried to break it but was unsuccessful.The object was sent to testing within the hospital.The procedure was continued with the one clip implanted, reducing mr to 1+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The complaint device was returned for evaluation.In this incident the return device analysis was unable to confirm the reported device contamination.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of emboli (thrombosis), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All the available information was investigated and the definitive cause for the reported device contamination and 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 CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9429133
• MDR Text Key: 169921858
• Report Number: 2024168-2019-14237
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: 04/16/2020
• Device Catalogue Number: CDS0501
• Device Lot Number: 90416U138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 47