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

Catalog Number 1012580-16

Device Problems Leak/Splash (1354); Physical Resistance (2578)

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombosis (2100)

Event Date 01/29/2015

Event Type  Death  

Event Description

It was reported that on (b)(4) 2015 during a procedure in the circumflex (cx) artery, a burr from a rotablader detached and became stuck in the vessel causing a perforation at the bifurcation of the cx and 2nd obtuse marginal (om) artery.The 2.8x16mm graftmaster stent system could not advance past the proximal perforation due to interactions with the burr.The graftmaster stent was deployed without issue; however, the perforation was not fully sealed.The patient was transferred to intensive care unit (icu) with plans for further treatment.On (b)(6) 2015, the patient was transferred back to the catheter lab to treat the distal portion of the perforation with coiling.No anticoagulants was given.During the procedure, the entire vessel thrombosed and the patient experienced cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed; however, the patient expired.No autopsy was performed as the death was deemed related to the perforation.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 4536895
• MDR Text Key: 5506291
• Report Number: 2024168-2015-00948
• 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
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 1012580-16
• Device Lot Number: 4013041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 62 YR