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

Catalog Number UNK XIENCE ALPINE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Stenosis (2263)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.The patient effect of stenosis appears to be related to circumstances of the procedure.The reported patient effect of stenosis is listed in the xience alpine everolimus eluting coronary stent systems instructions for use 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 Description

It was reported that a patient with two xience alpine stents implanted over 12 months prior in the right coronary artery returned symptomatic on (b)(6) 2018 with acute coronary syndrome.Angiography confirmed restenosis in one of the unknown xience alpine stents.The cardiologist attributed the restenosis to non-optimal stent apposition, but cannot confirm what caused the suboptimal apposition.The patient was implanted with another competitor stent as treatment in the affected area with a good patient outcome.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed medwatch report, it was confirmed that the angiogram showed restenosis - no imaging used.The physician guessed that this was due to mal-apposition of the stent.The physician thought there was under-expansion as the same stent distally did not have restenosis, so this lead him to believe that the restenosis was due to under-expansion.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7612127
• MDR Text Key: 111428957
• Report Number: 2024168-2018-04583
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE ALPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/22/2018
• Supplement Dates FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention