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

Catalog Number SGC0301

Device Problem Naturally Worn (2988)

Patient Problem Mitral Regurgitation (1964)

Event Date 10/25/2017

Event Type  Injury  

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 cardiac perforation (atrial perforation), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of atrial perforation appears to be related to patient morphology/pathology due to the floppy septum and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the torn septum.It was reported that on (b)(6) 2016 one mitraclip was implanted in the patient with degenerative mitral regurgitation (mr) reducing mr from grade 4 to 1.On (b)(6) 2017 a second mitraclip procedure was performed for recurrent mr grade 4+.The original mitraclip was stable and attached to both leaflets.At the re-clip procedure, during insertion of the steerable guide catheter (sgc) through the fossa ovalis of the floppy septum, the fossa ovalis became torn resulting in inadequate support of the sgc.There was difficulty steering to the valve because of the torn septum, but there were no device issues and one mitraclip was successfully implanted, reducing mr was reduced to grade 2+.There was no additional information 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: 7025468
• MDR Text Key: 91898425
• Report Number: 2024168-2017-08917
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70517U149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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): Other
• Patient Age: 89 YR
• Patient Weight: 54