MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550250-12
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2019
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.Concomitant medical products: dilatation cath: 2.5 x 15 apex, guide wire: mailman, guide catheter: al1.6f jl-4, jr-4.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficult to deploy; however, the reported physical resistance and subsequent treatment appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Exemption number e2019001 permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
The patient presented with a history or recurrent chest pain and the procedure was performed to treat lesions in the previously stented and clipped saphenous vein graft to circumflex marginal coronary artery.Two guide wires were placed and balloon angioplasty with a non-abbott balloon catheter was performed distally.Advancement was difficult due to the previously stented and clipped part of the graft.A 2.5 x 12 mm xience sierra was deployed in the distal lesion; however, adequate post dilatation with a non compliant balloon was not possible.An aneurysm was noted in the mid graft region and therefore a 4.00 x 19 mm graftmaster cover stent was attempted to be deployed.The graftmaster failed to cross the difficult anatomy despite numerous attempts and replacing the guide wires.The graftmaster did not cause or contribute to complications or adverse events.Some slow flow was noted as a result of the anatomy and as the graft was old the physician decided not to continue with further treatment attempts.The patient was reported to be stable post procedure and transferred back to his room for standard post procedure care.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8772004
• Report Number: 2024168-2019-05457
• Device Sequence Number: 1978613
• Product Code: NIQ
• UDI-Device Identifier: 08717648227080
• UDI-Public: 08717648227080
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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 Catalogue Number: 1550250-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/09/2019
• 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: 66 YR