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

Catalog Number	1125225-23
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance and difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.It was reported the sds was attempting to cross through the stent struts of a previously deployed stent, which likely contributed to the reported difficulties.It should be noted the xience alpine everolimus eluting coronary stent system electronic instructions for use (ifu) states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.In this case, it is likely the ifu deviation contributed to the reported difficulties.The investigation determined the reported failure to advance, difficult to remove, stent dislodgement and foreign body in patient appear to be related to the use error.The subsequent treatment appears 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 the distal circumflex (cx) and marginal arteries.After implanting an unspecified 2.25 x 28 mm stent in the cx, the 2.25 x 23 mm xience alpine was being advanced through the side struts to treat the marginal branch.However, after pushing the xience alpine stent back and forth for placement, it became caught through the side strut of the other stent and the stent dislodged from the delivery system.Therefore, three unspecified balloons were used to deploy and fully appose the xience alpine inside the 2.25 x 28 mm stent.A non-abbott stent was used to successfully treat the target lesion.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: 6852973
• Report Number: 2024168-2017-07365
• Device Sequence Number: 18954685
• Product Code: NIQ
• UDI-Device Identifier: 08717648199097
• UDI-Public: 08717648199097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 09/08/2017

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: 09/06/2019
• Device Catalogue Number: 1125225-23
• Device Lot Number: 6082641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/08/2017
• 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: 70 YR
• Patient Weight: 57