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

Catalog Number	1125300-28
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 similar incidents from this lot.The reported patient effects of angina and thrombosis are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported difficulty and patient effects, 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 of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mildly tortuous, mildly calcified, 75% stenosed, mid left anterior descending (lad) coronary artery using a 3.00 x 28 mm xience alpine stent delivery system (sds).The sds was advanced to the lesion and the stent implant was successfully deployed.Approximately one hour post procedure, the patient developed chest pain and a thrombus was confirmed by angiography and intravascular ultrasound (ivus) to be within the stent implant.There was a possibility that the apposition of the stent implant was not complete as it was an angiography guided percutaneous coronary intervention (pci).Thrombus aspiration was performed and an unspecified stent implant was deployed overlapping the proximal end of the xience alpine stent.The timi flow increased from 1 to 3 following the intervention.It was the physician's opinion that the relationship between the thrombus and the xience alpine stent was low.No additional information 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: 7430440
• Report Number: 2024168-2018-02778
• Device Sequence Number: 11250157
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 11/06/2020
• Device Catalogue Number: 1125300-28
• Device Lot Number: 7102361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/13/2018
• 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