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

Catalog Number	1125400-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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 reported from this lot.The investigation was unable to determine a conclusive cause for the stent malapposition; however the treatment appears to be related to circumstances of the procedure.It should be noted the xience alpine everolimus eluting coronary stent system electronic instructions for use states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions.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.The other xience alpine device referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient was admitted (b)(6) 2016 with st-elevation myocardial infarction (stemi) and a 3.5x23mm xience alpine stent was implanted without issue in the distal right coronary artery.The next day and while the patient was still in the hospital the patient was experiencing angina and the physician brought the patient back for an angiography check.Angiography confirmed thrombus in the 3.5x23mm alpine stent and thrombectomy was performed.A 4x38mm xience alpine stent was inserted through the 3.5x23mm alpine stent to treat the thrombosis and due to the length of the lesion.It was noted that both stents were not fully apposed to the vessel wall.Thus, post-dilatation was performed using a 4.5mm balloon to ensure appropriate wall apposition.There was 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: 5933601
• Report Number: 2024168-2016-05927
• Device Sequence Number: 16451307
• Product Code: NIQ
• UDI-Device Identifier: 08717648199660
• UDI-Public: (01)08717648199660(17)190131(10)6012541
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1125400-38
• Device Lot Number: 6012541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/07/2016
• 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: STENT: 3.5X23 XIENCE ALPINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 125