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

Catalog Number	1012582-26
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
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 identified no similar incidents from this lot.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use (ifu), states: note the product use by date specified on the package.In addition, it should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, ifu states: deploy the stent graft slowly by pressurizing the delivery system in 2-atm increments, every 5 seconds, until the stent graft is completely expanded.Fully expand the stent graft by inflating to nominal pressure at a minimum.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the patient presented with a free perforation in the saphenous vein graft (svg) to the right coronary artery (rca).On (b)(6) 2016, a 4.0x26 rx graftmaster covered stent that had expired on 07/31/2016, was deployed at 9 atmospheres and sealed the perforation.Use of the graftmaster device did not cause or contribute to complications or adverse events.There have been no adverse patient sequelae.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: 6192052
• Report Number: 2024168-2016-09088
• Device Sequence Number: 13720611
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: (01)08717648176463(17)160731(10)4082641
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 1012582-26
• Device Lot Number: 4082641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 99