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 Air Embolism (1697); Cardiac Arrest (1762); Death (1802)

Event Date 12/14/2018

Event Type  Death  

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 the air embolism.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were implanted, reducing the mr to 3.Approximately 45 minutes post procedure, the patient went into cardiac arrest and was intubated.The patient is stable; however, required prolonged hospitalization.The physician stated that air was likely introduced at some point during the procedure but does not believe it was from the mitraclip devices.It is unknown what caused the air embolism.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of air emboli and cardiac arrest are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Patient codes: 1802 labeled.Internal file number - (b)(4).The device was not returned for evaluation.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, based on the reported information, the reported death is not related to the device or the procedure.The reported patient effect of death is listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed medwatch report, additional information was received that on (b)(6) 2018, 6 days post procedure, the patient expired.It was reported that the clips were stable on both leaflets at the time of death.In the physicians opinion, death was unrelated to the procedure and the mitraclip device.No additional information was provided.

• 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
• MDR Report Key: 8217739
• MDR Text Key: 132088729
• Report Number: 2024168-2019-00065
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80416U142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS; 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 62