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	Intimal Dissection (1333)
Date of Event	07/11/2017
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.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient presented with elevated troponin levels and myocardial infarction.The procedure was to treat heavily calcified, de novo lesions in the mildly tortuous proximal diagonal artery and the mildly tortuous proximal left anterior descending (lad) coronary artery.An attempt was made to cross the lesion in the diagonal artery with a 2.25x12mm rx xience alpine stent delivery system (sds), but this device failed to cross due to patient anatomy and was withdrawn.There were no other device issues, no adverse patient effects, and no delay related to use of this device.An attempt was made to cross the lad lesion with a 3.0x15mm rx xience alpine sds, but this device also failed to cross due to patient anatomy and a dissection occurred during the attempt to cross the lad.No additional attempts to cross were made with stent systems.The diagonal and lad lesions, and the lad dissection, were successfully treated via balloon angioplasty.There were no adverse patient sequelae.The patient was discharged home the following day.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: 6745829
• Report Number: 2024168-2017-06227
• Device Sequence Number: 856313
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: 08717648199349
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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: 05/25/2020
• Device Catalogue Number: 1125300-15
• Device Lot Number: 7050461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 07/26/2017
• 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: 87 YR
• Patient Weight: 48