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

Catalog Number	1125225-12
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	09/13/2018
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 was not performed as the lot number was not reported.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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The whisper device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately tortuous lesion in the circumflex artery.A 014 whisper extra support guide wire was advanced to the lesion; however, resistance with the anatomy was felt.A 2.25x12mm xience alpine stent was advanced and successfully deployed.An attempt to remove the guide wire was made; however, it became stuck with the deployed stent and the guide wire could not be advanced or removed.An uninflated balloon was advanced to help release the guide wire, but was unsuccessful.It was noted that the tip of the guide wire separated.The tip was left in the anatomy and the patient was sent back to the intensive care unit for observation.A few hours later the patient had chest pain and was sent back to the catheter lab.Angiography confirmed stent thrombosis.Balloon angioplasty was performed; however, since the hospital does not have a surgical center it was decided to send the patient to another hospital for further intervention.The patient was transferred to another hospital and additional unspecified stents were deployed to successfully treat the thrombosis.The patient is doing well.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: 7908117
• Report Number: 2024168-2018-07384
• Device Sequence Number: 1472627
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: 08717648199066
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 1125225-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/25/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR