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

Catalog Number	1550275-18
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: sion blue, guide cath: hyperion 6fr jl 3.5.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.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 procedure was to treat a lesion located in a moderately tortuous, heavily calcified, 90% stenosed, obtuse marginal branch of the circumflex artery.After pre-dilatation, the 2.75 x 18 mm xience sierra stent delivery system (sds) failed to cross.During removal anatomical resistance was met; the sds was removed and a different unspecified device was used to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number (b)(4).Correction: remove statement - the customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 8391646
• Report Number: 2024168-2019-01689
• Device Sequence Number: 16575154
• Product Code: NIQ
• UDI-Device Identifier: 08717648227189
• UDI-Public: 08717648227189
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 04/10/2021
• Device Catalogue Number: 1550275-18
• Device Lot Number: 8032141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 52