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

Catalog Number SGC0101

Device Problems Difficult To Position (1467); Physical Resistance (2578)

Patient Problem Atrial Perforation (2511)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guiding catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report that after the steerable guiding catheter (sgc) was removed, the atrial septal defect (asd) was very large and was treated with an asd occluder, which is considered medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The patient had a very thin/floppy septum; therefore, an occluder was planned to be placed on the septum post procedure.The steerable guiding catheter (sgc) was advanced and it was noted that it was difficult to get into position due the floppy septum, but ultimately successful.Two clips were implanted, reducing the mr to 1.After the steerable guiding catheter (sgc) was removed, the atrial septal defect (asd) was very large.It was noted that the thin septum, tricuspid regurgitation and the sgc contributed to the enlarged asd.A larger than planned asd occluder was implanted for treatment and the patient was confirmed to be stable post procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of atrial septal defect (asd), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported physical resistance while advancing the steerable guide catheter (sgc) appears to be a result of patient morphology/pathology.The reported patient effect of an asd was likely a result of patient and procedural conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

• 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: 6045516
• MDR Text Key: 58000931
• Report Number: 2024168-2016-07138
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60615U218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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
• Treatment: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 54