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

Catalog Number	1012583-19
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Thrombosis (2100)
Date of Event	07/26/2017
Type of Reportable Event	Death
Additional 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 that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of thrombosis and death as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), are known patient effects that may be associated with use of a coronary stent in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported failure to seal the perforation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 3.5x19 graftmaster device is filed under a separate medwatch manufacturer report reference number.
Event or Problem Description
It was reported that the 3.5 x 19 mm (first) and 4.5 x 19 mm (second) graftmaster rx stents were used for treatment of a perforation in the left anterior descending coronary artery that was heavily calcified.After implanting the first graftmaster, the perforation was discovered to be larger than initially anticipated and the second graftmaster was implanted.The patient subsequently expired the same day from cardiopulmonary arrest complicated by hemorrhage from perforation and acute thrombotic occlusion of the graftmaster stents.The patient expired prior to surgical repair.In the opinion of the physician, the use of the devices did not cause or contribute to the patient death.No autopsy was performed.The patient's health was declining prior to graftmaster use.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6836507
• Report Number: 2024168-2017-07194
• Device Sequence Number: 16321650
• Product Code: MAF
• UDI-Device Identifier: 08717648176487
• UDI-Public: 08717648176487
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1012583-19
• Device Lot Number: 6051141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Weight: 69