MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1120300-08

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Dyspnea (1816)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient no: (b)(6).It was reported that on (b)(6) 2017, a 3.0 x 8 mm xience alpine stent was successfully implanted.Final optical coherence tomography (oct) noted good stent apposition.On (b)(6) 2018, the patient presented with chest pain and was hospitalized.Evaluation was performed and the patient was discharged on (b)(6) 2018.No additional information was provided.

Event Description

Patient id: (b)(6).Subsequent to the initial 30-day medwathc report, the following information was provided.The index procedure was performed on (b)(6)2017 to treat a lesion in the mid left anterior descending coronary artery.On (b)(6)2018 , the patient was re-hospitalized with chest pain and dyspnea.The patient was admitted for evaluation; however, no additional intervention was performed.The patient was discharged to home, with instructions to follow up at the cardiology outpatient department.No additional information was provided.

Manufacturer Narrative

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.The reported patient effect of angina is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.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.B3 :date of event.D6: implant date corrected.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10311597
• MDR Text Key: 199984375
• Report Number: 2024168-2020-06135
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Catalogue Number: 1120300-08
• Device Lot Number: 6120741
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR