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

Catalog Number SGC0301

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

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888)

Event Date 07/05/2018

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

Event Description

This is conservatively filed to report a dissection during the procedure.It was reported that this was a mitraclip procedure to degenerative mitral regurgitation (mr) with am mr grade of 4.The steerable guide catheter (sgc) was advanced without issue and the mitraclip was inserted.One clip was implanted successfully, reducing mr to <1.Upon removal of devices, there was bleeding coming from the groin.A dissection was noted in the femoral vein, which was ballooned and stented.It is the physicians opinion, the dissection was possibly caused by the guide wire; however, this was not confirmed.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: lot number.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.A definitive cause for the reported intimal dissection cannot be determined in this incident.The reported hemorrhage appears to be related to procedural circumstances as dissection was noted in the femoral vein.It should be noted that the reported patient effects of vascular dissection and hemorrhage requiring transfusion, are listed in the mitraclip system instructions for use (ifu), as known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality deficiency 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: 7718737
• MDR Text Key: 114987812
• Report Number: 2024168-2018-05742
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80410U118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118