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

Catalog Number	1125250-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
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.Visual and dimensional inspections were performed on the returned device.The stent dislodgement was confirmed.The difficulty removing the protective sheath could not be replicated in a testing environment due to the condition of the returned device.The investigation was unable to determine a conclusive cause for the reported difficulties.The xience alpine everolimus eluting coronary stent system instructions for use states: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.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.Based on the information reviewed, 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 resistance was felt when the protective sheath was removed from the 2.5x28 xience alpine stent delivery system (sds).The sds was advanced to the heavily tortuous, moderately calcified mid left circumflex coronary artery and inflated to 12 atmospheres.It was then noted that the stent was not on the sds.The patient was checked for a dislodged stent with multiple cine views and oct, but the stent was not found in the patient.Another xience alpine was used to complete the procedure without further incident.When the procedure was completed, the stent was found inside the sheath.The stent had come off the sds when the protective sheath was removed.There were no adverse patient effects and no clinically significant delay in the procedure.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: 6028899
• Report Number: 2024168-2016-06937
• Device Sequence Number: 77670
• Product Code: NIQ
• UDI-Device Identifier: 08717648199196
• UDI-Public: (01)08717648199196(17)190606(10)6052641
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/13/2016

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: 06/06/2019
• Device Catalogue Number: 1125250-28
• Device Lot Number: 6052641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/13/2016
• 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 WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II
• Patient Age: 77 YR
• Patient Weight: 68