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

Catalog Number	1125350-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
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.(b)(4).Evaluation summary: the device was returned for analysis.The reported balloon rupture was unable to be confirmed.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 other similar incidents reported from this lot.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use states: with the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.The investigation determined the reported/noted balloon rupture, outer member tears/holes, inner/outer member wrinkles/grip marks appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery which did not have any tortuosity or calcification.The patient presented with segment elevated myocardial infarction (stemi).A 3.5 x 15 mm xience alpine stent delivery system was used and did not meet any resistance during advancement.However, the device was not prepped outside of the anatomy.The device pulled negative without any issues and there were no bubbles; however, the balloon would not inflate after two attempts to inflate the device.The pressure gauge did not change and contrast leakage was noted to be coming from the balloon.Therefore, the device was removed and another 3.5 x 15 mm xience alpine stent delivery system was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 7382465
• Report Number: 2024168-2018-02292
• Device Sequence Number: 13766283
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: 08717648199523
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 03/29/2018

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: 12/05/2020
• Device Catalogue Number: 1125350-15
• Device Lot Number: 7112161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR