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

Catalog Number SGC01ST

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

Patient Problems High Blood Pressure/ Hypertension (1908); Atrial Perforation (2511)

Event Date 03/03/2016

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 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 being filed under a separate medwatch mfr number.

Event Description

This is filed to report that one month post-procedure, the patient condition worsened.An atrial septal defect (asd) and pulmonary hypertension were observed prolonging hospitalization.It was reported that the initial mitraclip procedure was performed on (b)(6) 2016, to treat mixed mitral regurgitation (mr) with a grade of 3-4.Three clips were implanted, reducing the mr to 1-2.One month post-procedure, the patient condition worsened.An atrial septal defect (asd) was observed with high pulmonary hypertension and increased mr of 3+.The implanted clips were confirmed to be stable on the leaflets and there were no issues with the implanted clips.The decision was made to close the asd as soon as the patient is more stable.The patient has not left the hospital since the procedure and his condition has worsened due to the asd, pulmonary infection and worsening of pre-existing renal failure requiring dialysis.The worsened renal failure was attributed to the infectious status and hypotension during the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effects of hypertension and atrial septal defect (asd), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effects appear to be related to procedural conditions, as the asd was likely a result of the procedure; during the procedure, the sgc crosses the septum to access the left atrium.The reported pulmonary hypertension was likely a cascading effect of the asd.The reported additional therapy/non-surgical treatment and hospitalization were a result of case specific circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 5522878
• MDR Text Key: 41056497
• Report Number: 2024168-2016-01886
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50922U126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Age: 79 YR
• Patient Weight: 79