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

Catalog Number	SGC0101
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 pericardial effusion, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effect of pericardial effusion and the relationship to the device, if any, cannot be determined, 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 the pericardial effusion.It was reported that on (b)(6) 2017, the patient, with degenerative mitral regurgitation, underwent a mitraclip procedure.The steerable guide catheter (sgc) was advanced without difficulty into the left atrium.The first clip delivery system (cds) was advanced and the clip deployed without issue.A second cds was advanced; however, a pericardial effusion was noted and the cds was removed without deployment of the second clip.The sgc was removed without difficulty and the effusion stopped.Pericardiocentesis was performed to treat the effusion.The cause of the pericardial effusion was unknown, but the physician reported that after the first cds was removed, the sgc was pulled back to the septum and then re-advanced when the second cds was inserted.It was thought that possibly, when the sgc was pulled back, it was pulled back across the septum into the right atrium.When the sgc was re-advanced into position in the left atrium, it entered a flap in the septum, causing the pericardial effusion.There was no flap noted prior to, during or after the procedure.There was no damage noted to the septum after the sgc was removed.Other than the pericardiocentesis, no additional intervention was performed to treat the pericardial effusion.The patient remained in stable condition during the procedure and post procedure.No additional clips were implanted and the degenerative mitral regurgitation (mr) was reduced from grade 4+ to grade 2-3.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: 6274859
• Report Number: 2024168-2017-00662
• Device Sequence Number: 1057381
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170630(10)60601U133
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/24/2017

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: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60601U133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 01/24/2017
• 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: 2 CLIP DELIVERY SYSTEMS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 76