MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012581-19

Device Problem Leak/Splash (1354)

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045); Ventricular Tachycardia (2132)

Event Date 12/30/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other incidents for a stent graft leak reported from this lot.The reported patient effects of ventricular tachycardia and death, as listed in the coronary stent graft system, graftmaster rx instructions for use (ifu) are known patient effects that may be associated with coronary stenting.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.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

It was reported that on (b)(6) 2014, the patient presented with a myocardial infarction from a blocked right coronary artery (rca), resulting in hemodynamic instability.During the percutaneous coronary intervention a spiral dissection/perforation of the vessel occurred.A 3.5x19mm graftmaster was successfully implanted; however, due to the status of the vessel, the physician was unsure if the stent was implanted in the true lumen or in the intima.Reportedly, it took approximately 20 minutes to seal the perforation using extensive ballooning, perhaps due to bivalirudin use.Despite restoration of blood flow through the rca, the patient developed respiratory distress, was intubated, then experienced cardiac arrest with recurrent ventricular tachycardia and subsequently died.There was no additional information provided.

Manufacturer Narrative

(b)(4).Actual patient weight (b)(6).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4443326
• MDR Text Key: 12837297
• Report Number: 2024168-2015-00360
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 1012581-19
• Device Lot Number: 4082641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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: BIVALIRUDIN, ANGIOMAX
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Weight: 61