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

Catalog Number	SGC0101
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	01/03/2017
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 atrial septal defect, as listed in the mitraclip system instructions for use (ifu) is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of atrial septal defect appears to be related to procedural conditions, as the steerable guiding catheter must be advanced through the septum in order to access the right atrium and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
This is filed to report that after the steerable guiding catheter (sgc) was removed, an atrial septal defect (asd) was observed which was treated with a septal occluder.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.There were no issues noted during the procedure.Two clips were implanted, reducing the mr to 1+.After the steerable guiding catheter (sgc) was removed and the patient was being weaned off of the ventilator, the oxygen saturation started to drop and a right to left shunt was observed through the atrial septal defect (asd).A 20 mm septal occluder was used to close the asd and the ventilator was removed without issue.After the asd was closed, the patient was confirmed to be stable.It is the physician opinion that the issue was not due to the mitraclip device, but that the blood was flowing both ways through the septal puncture.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: 6268756
• Report Number: 2024168-2017-00610
• Device Sequence Number: 763465
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170630(10)60601U110
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/20/2017

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: 60601U110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2017
• Initial Report FDA Received Date: 01/20/2017
• 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: MITRACLIP SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 100