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

Catalog Number SGC0302

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

Patient Problem Fistula (1862)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system is filed under mfr report # 2024168-2017-05663.

Event Description

This is filed to report that during use of the steerable guide catheter (sgc) a fistula was noted.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The mitraclip delivery system (cds) was advanced to the mitral valve.The clip was deployed on the mitral valve leaflets without issue; however, during removal the gripper line, when approximately 60 cm of the gripper line was removed, resistance was felt and the gripper line could not be removed.Trouble shooting attempts were unsuccessful.The decision was made to remove the devices, leaving the implanted clip and gripper line in place.Both ends of the gripper line were observed outside of the groin.Another unsuccessful attempt to remove the gripper line was performed.At this point a fistula was noted at the access site.Reportedly, the fistula was caused during the initial femoral puncture; however, the sgc may have contributed to the enlargement of the fistula.A stent graft and ballooning were used to seal the fistula.Both ends of the gripper line were then cut at the groin level.The patient remained stable.A total of one clip was implanted, reducing mr to 1.No additional treatment was planned.There was no additional information provided.

Manufacturer Narrative

(b)(4).Correction: catalog #.The device was not returned for evaluation.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 similar incidents reported from this lot.The reported patient effect of an arterio-venous fistula, as listed in the mitraclip system electronic instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of a fistula appears to be related to operational context of the procedure and not related to the mitraclip devices and 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: 6694971
• MDR Text Key: 79348171
• Report Number: 2024168-2017-05710
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161985
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70221U123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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): Required Intervention