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	09/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 investigation could not determine a conclusive cause for the reported device operates differently (failure to seal).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.The other two graftmaster stents referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a coronary procedure to treat a target lesion in the saphenous vein graft to the 1st diagonal artery.A perforation occurred.The 2.8 x 16 mm graftmaster stent, the 2.8 x 19 mm graftmaster stent and the 4.0 x 26 mm graftmaster stent were implanted in overlapping fashion.It was noted that the perforation did not seal.It was thought that the perforation may have been larger than initially anticipated; however, it is not known why the perforation was not sealed.A coil was placed to seal the perforation.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: 6894618
• Report Number: 2024168-2017-07778
• Device Sequence Number: 116305
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/26/2017

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: 1012582-26
• Device Lot Number: 6051141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 2.8X16MM GRAFTMASTER, 2.8X19MM GRAFTMASTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82