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

Catalog Number	1012583-16
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual and functional inspection was performed on the returned device.A pinhole leak was noted, confirming the reported failure to deploy.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.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 4.0 x 16 mm graftmaster referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that a perforation occurred in the ostial saphenous vein bypass to diagonal and circumflex graft with the use of an unspecified device.Three graftmaster stents were opened and prepared.A 4.5 x 16 mm graftmaster was attempted but the stent failed to deploy from the balloon after two attempts to inflate at 18 atmosphere (atm); the device was removed from the anatomy.A 4.0 x 16 mm graftmaster stent was implanted but failed to achieve hemostasis and a 4.5 x 19 mm graftmaster stent was used successfully to treat the perforation.There was no reported adverse patient sequela or a clinically significant delay in the procedure.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: 6814953
• Report Number: 2024168-2017-06886
• Device Sequence Number: 10983144
• Product Code: MAF
• UDI-Device Identifier: 08717648176470
• UDI-Public: 08717648176470
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: 08/31/2018
• Device Catalogue Number: 1012583-16
• Device Lot Number: 6090141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/23/2017
• 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: GUIDE CATHETER: GUIDELINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 82