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

Catalog Number SGC0301

Device Problem Physical Resistance (2578)

Patient Problem Atrial Perforation (2511)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the atrial septal defect (asd).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The first clip delivery system (cds) was advanced to the mitral valve and the clip was deployed, reducing the mr to <1.After deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).While implanting the second clip, the steerable guide catheter (sgc) pulled back across septum.The sgc was advanced, with resistance, back across septum.Two additional clips were implanted, one on either side of the slda, to stabilize the clip.Mr was reduced to <1.Post-procedure, there was a larger than normal asd.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 lot.Additionally, a review of the complaint history identified no other 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 a definitive cause for the reported physical resistance with the anatomy could not be determined.The reported patient effect of asd was likely a result of procedural conditions and likely due to the difficulty advancing the steerable guide catheter (sgc).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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: 6635260
• MDR Text Key: 77393867
• Report Number: 2024168-2017-04987
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70130U155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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: 86 YR
• Patient Weight: 63