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

Catalog Number	1125300-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced into the copilot rotating hemostatic valve (rhv), the rhv was not fully opened and as a result an interaction between the stent and rhv resulted in the stent dislodgment.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that after prepping a 3.5x15mm rx xience alpine stent delivery system (sds) without issue, the sds was advanced without resistance into a copilot rotating hemostatic valve (rhv), which was connected to the patient access site.However, immediately after entering the copilot rhv, it was noted that the xience alpine stent had dislodged proximally onto the sds shaft outside of the patient anatomy.The sds was simply withdrawn from the copilot without resistance.A new unspecified xience alpine was used with the same copilot without issue to successfully treat the patient.There were no adverse patient effects and no occurrence of a clinically significant delay.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: 6474149
• Report Number: 2024168-2017-02943
• Device Sequence Number: 10975417
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: (01)08717648199349(17)190202(10)6012141
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/07/2017

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: 02/02/2019
• Device Catalogue Number: 1125300-15
• Device Lot Number: 6012141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/07/2017
• 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: RHV: COPILOT
• Patient Age: 68 YR
• Patient Weight: 73