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

Catalog Number SGC01ST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records and information provided to abbott vascular.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guiding catheter (sgc).The reported patient effect of atrial perforation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported atrial septal defect was likely related to procedural conditions, as the sgc crosses the septum during positioning.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as a patent foramen ovale (pfo) occluder was used to close the shunt.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report that after the steerable guiding catheter (sgc) was removed, a shunt was observed at the atrial septum, which required a patent foramen ovale (pfo) occluder and is considered intervention to prevent injury.It was reported that the initial mitraclip procedure was performed on (b)(6) 2015, to treat mixed mitral regurgitation (mr) with a grade of 3.One clip was implanted and the mr was reduced to <1.On (b)(6) 2015, a second mitraclip procedure was performed due to progression of disease.One clip was implanted medial to the first one and the mr was reduced to <1.After the steerable guiding catheter (sgc) was removed, a left-right shunt was observed at the artial septum; therefore, a patent foramen ovale (pfo) occluder was used to close the shunt.The patient was confirmed to be clinically stable post-procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5212837
• MDR Text Key: 30833540
• Report Number: 2024168-2015-06681
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50717U111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention