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 Problems Embolism (1829); Thrombosis (2100)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the clot in the left atrium (la), requiring treatment and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr).After the steerable guiding catheter (sgc) was advanced to the la and removal of the dilator and guide wire was started, a clot was observed in the la.The sgc was removed and the clot was watched, but it didnt move from the la.An introducer sheath was used to re-advance the guide wire and the clot remained in the la.While assessing the clot, it disappeared, and it was suspected that it went to the lungs.The activated clotting time (act) was checked throughout the procedure.The guide wire was removed and the case was aborted.All devices were removed, inspected and confirmed to be clean of any clots or damage.The patient was maintained on heparin and hospitalized for assessment.A new mitraclip procedure will be scheduled for a later date.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.Although there was no reported device malfunction/issue, as a conservative measure, the device was visually inspected; no device damage was identified.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.The reported patient effects of embolism and thrombosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The investigation was unable to determine a definitive cause for this incident.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 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: 6074650
• MDR Text Key: 59009380
• Report Number: 2024168-2016-07534
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 51216U111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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: DILATOR, GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 75