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

Catalog Number SGC0101

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

Patient Problem Atrial Perforation (2511)

Event Date 03/30/2016

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 relevant information.The mitraclip is filed under a separate medwatch report number.

Event Description

This report is filed for the atrial septal defect.It was reported that on (b)(6) 2016, two mitraclips were implanted reducing mitral regurgitation (mr) from grade 4 to 2-3.Sometime after the clips were implanted mr increased.On (b)(6) 2016, an echocardiogram was performed, noting an atrial septal defect and increased mr (grade 4).A single leaflet device attachment (slda) was suspected.On (b)(6) 2016 a second clip procedure was planned.The slda was confirmed in one of the two implanted clips.The other clip remained attached to both mitral valve leaflets.During use of a non-abbott guide wire, a pericardial effusion was noted in the left atrium.The patient subsequently expired from cardiac tamponade.No additional information was provided.

Manufacturer Narrative

(b)(4).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 is a known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effect appears to be a result of procedural conditions, as the steerable guiding catheter is inserted through the septum in order to access the left atrium for positioning and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the 30-day medical device report, the following information was received: there was difficulty with visualization at some portions of the first clip procedure on (b)(6) 2016.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: 6104426
• MDR Text Key: 59972281
• Report Number: 2024168-2016-07977
• 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: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50814U105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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
• Treatment: TWO CLIP DELIVERY SYSTEMS
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 66