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

Catalog Number SGC01ST

Device Problem Device Slipped (1584)

Patient Problems Mitral Regurgitation (1964); Atrial Perforation (2511)

Event Date 09/24/2015

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 discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed because an atrial septal defect (asd) occurred and mitral valve replacement surgery was performed, which is considered a permanent impairment.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and challenging patient anatomy due to prolapsed leaflets.After transseptal puncture, the steerable guide catheter (sgc) and the clip delivery system (cds) were placed.There was difficulty grasping the leaflets due to the prolapsed leaflets.Three to four attempts to grasps the leaflets could not reduce mr; therefore, the cds was removed.After removal of the sgc, an atrial septal defect (asd) with a shunt was noted.It is believed that the asd may have occurred during advancement of the sgc when it slipped from the left atrium to the right atrium.No treatment was performed for the shunt.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure; however, the decision was made to abort the procedure at that time.Mitral valve replacement surgery and coronary artery bypass graft (cabg) surgery were performed, and the patient remains hospitalized.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be performed.The analysis of this complaint was an assessment of the information provided to abbott vascular, the manufacturing records, and complaint history.The investigation determined that the reported guide steering issues resulting in slippage of the sgc appears to be related to user technique/procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The patient effect of atrial septal defect (asd) is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initial medwatch report, additional information was received that during grasping attempts, there was unexpected steering of the steerable guide catheter.The sgc tip temporarily came in contact with the right atrial side.The entangled clip was removed from the chordae with inverse rotation and minor force.

• 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: 5159770
• MDR Text Key: 28672684
• Report Number: 2024168-2015-06171
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50205U224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 85 YR