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

Catalog Number 1012581-16

Device Problem Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 06/08/2015

Event Type  Death  

Event Description

Subsequent to the initial medwatch report, additional information was received: the patient presented with a massive st elevation myocardial infarction and was found to have an occluded left anterior descending coronary artery just distal to the first diagonal artery.After implantation of the three graftmaster stents, the patient was pain free and the st segment was significantly improved, but there was still a perforation into the ventricle.Additionally, timi flow was less than 3 at the apex.The 2nd diagonal artery was noted to be closed due to placement of the most proximal covered stent.No additional information was provided.

Manufacturer Narrative

(b)(4).Dilatation catheter: nc quantum; guide wire: 0.014 choice floppy (x2); sheath: 6 fr xblad 4.0 cm.Other: heparin, intra-aortic balloon pump.

Event Description

It was reported that during a mid to proximal left anterior descending coronary artery (lad) intervention, a perforation occurred from use of a non-abbott device.Three graftmaster stents were implanted to treat the vessel, but failed to seal the perforation.The patient was stabilized and transferred to a different facility for additional intervention of the vessel.At some point during that hospitalization, the patient died.The exact cause and date of death was not reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The stent remains in the vessel.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 this complaint.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.The reported patient effect of death, as listed in the graftmaster rapid exchange (rx) coronary stent graft system, instructions for use, is a known patient effect that may be associated with coronary stenting.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The other two graftmaster devices referenced are filed under separate medwatch mfr numbers.

• 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: 4870010
• MDR Text Key: 6009950
• Report Number: 2024168-2015-03596
• 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: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1012581-16
• Device Lot Number: 4030341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: CONCOMITANT MEDICAL PRODUCTS
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 116