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

Catalog Number SGC01ST

Device Problems Device Slipped (1584); Physical Resistance (2578)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Pain (1994); Tissue Damage (2104)

Event Date 05/15/2017

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 steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed for the patient death.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.During the procedure there was difficulty advancing the steerable guide catheter (sgc) through the very tortuous inferior vena cava (ivc).It was observed on fluoroscopy that the dilator was not correctly positioned, so the dilator was readjusted to avoid injury to the vessels.The procedure was perfectly performed with the placement of 1 clip and a reduction in mr to 1-2.After 1 hour the mr was found to be less than grade 1 as observed in a transesophageal echocardiogram.Post procedure, the patient was taken off the ventilator and blood pressure was normal at 103/54 mm hg.Approximately one hour after the clip procedure, the patient had stomach pain and did not feel well.Inferior vena cava (ivc) injury was suspected and the patient was taken for surgical repair of the vena cava, an injury to the ivc was not noted during the mitraclip procedure, but during surgery, tears were noted in the ivc.Additionally, the blood pressure remained very low.During the surgery, the patient died due to the tears in the ivc, which may have occurred during advancement of the sgc.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of hypotension, pain, vessel perforation or laceration and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and the reported physical resistance during sgc advancement and slippage of the dilator (movement back into the sgc) appear to be a result of patient morphology/pathology and likely due to the tortuous vessel anatomy.The reported patient effect of tissue damage was likely a result of procedural conditions, as the movement of the dilator back into the sgc likely created an unsmooth transition between the two devices, tearing the ivc when the physician attempted to advance the system.The reported hypotension, pain, and patient death were likely symptoms/cascading effects of the tears in the ivc and complications of the vascular surgery.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 6628944
• MDR Text Key: 77193876
• Report Number: 2024168-2017-04922
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60826U107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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): Death
• Patient Weight: 80