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

Catalog Number	SGC0101
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 emobli (thrombosis), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed a conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under a separate medwatch report number.
Event or Problem Description
This is filed to report the clot that was observed.It was reported that the initial mitraclip procedure was performed on (b)(6) 2016, to treat degenerative mitral regurgitation (mr) with a grade of 4+.Two clips ((b)(4)) were implanted, reducing the mr to <1.On (b)(6) 2017, the patient presented with dyspnea and it was found that one clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).The mr had increased to 4+.On (b)(6) 2017, a second mitraclip procedure was performed in attempt to stabilize the slda clip and reduce the mr.The steerable guiding catheter (sgc) was advanced to the left atrium; however, a clot was observed on the right side of the heart.The sgc was removed and the clot was aspirated.The procedure was discontinued, and the patient will be brought back at a later date for a new procedure.The patient is currently stable.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Common Device Name: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6327723
• Report Number: 2024168-2017-01163
• Device Sequence Number: 1106041
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170531(10)60517U133
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60517U133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 92