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

Catalog Number	SGC0101
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	03/15/2017
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.A conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined.The reported patient effect of thrombus, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This event is filed for thrombus observed during use with the steerable guide catheter (sgc).It was reported that the patient, with degenerative mitral regurgitation, underwent a mitraclip procedure.The sgc was inserted, and the first cds (60808u129) was advanced into the patient anatomy without difficulty; however, a cable break occurred.The cds was removed and replaced.A second cds was advanced into the anatomy and the clip was deployed, reducing the mr from 4 to 2.A third cds (60808u126) was advanced into the left ventricle; however, thrombus was noted in the right atrium and the procedure was stopped.The activated clotting time (act) was at 300.No additional intervention was performed to treat the thrombus.The procedure ended with the mr at grade 2.Post procedure, the patient is in stable condition.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: 6473039
• Report Number: 2024168-2017-02927
• Device Sequence Number: 16226399
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170731(10)60701U246
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• 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): 04/07/2017

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: 07/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60701U246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 88