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

Catalog Number	1012584-26
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: guide wire: 35 j, sheath: 7 french, other: 5-french pigtail.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the procedure was to treat an aneurysm located in the saphenous vein graft (svg) to the obtuse marginal.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use section 3 states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.The reported patient effect of perforation is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the graftmaster 4.8 x 26 mm covered stent was successfully deployed at 16 atmospheres to treat an aneurysm located in the saphenous vein graft (svg) to the obtuse marginal completely sealing the aneurysm.However, this resulted in a perforation of the saphenous vein graft at the inflow of the initial stent as a complication which was sealed successfully with another graftmaster 4.8 x 26 mm covered stent.The second device was able to successfully overlap the initial stent and seal the perforation.Intravascular ultrasound of the saphenous vein graft, post stent deployment, revealed excellent stent expansion, well apposed to the vessel wall.Patient tolerated procedure well with no complications.The patient will undergo a repeat computerized tomography coronary angiography in 3-6 months.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: 7085212
• Report Number: 2024168-2017-09423
• Device Sequence Number: 1450168
• Product Code: MAF
• UDI-Device Identifier: 08717648176524
• UDI-Public: 08717648176524
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1012584-26
• Device Lot Number: 6021641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/05/2017
• 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: Required Intervention
• Patient Age: 82 YR