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

Catalog Number 1011709-33

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

Patient Problems Angina (1710); Dyspnea (1816); Headache (1880)

Event Date 04/23/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Stent: 2.25 x 28 mm xience prime, 3.0 x 18 mm xience prime.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effect of angina is listed in the xience prime / xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.

Event Description

It was reported that on (b)(6) 2014, the patient was admitted with chest pain.On (b)(6) 2014, a 3.0 x 33 mm xience prime stent was implanted in the proximal left anterior descending (lad) artery, a 2.25 x 28 mm xience prime stent was implanted in the distal left circumflex and a 3.0 x 18 mm xience prime stent was implanted in the proximal right coronary artery.The patient was discharged on (b)(6) 2014.On (b)(6) 2014 the patient was re-hospitalized with shortness of breath, chest pain and headache.Medications were administered and the patient was discharged home on (b)(6) 2014.On (b)(6) 2014 the patient was re-hospitalized with paroxysmal chest tightness and shortness of breath.Medications were administered and the patient was discharged home on (b)(6) 2014.On (b)(6) 2014 the patient was re-hospitalized due to paroxysmal chest tightness and shortness of breath.Medications were administered and the patient was discharged on (b)(6) 2014.On (b)(6) 2014 the patient was re-hospitalized with chest pain.Medications were administered and the patient was discharged home on (b)(6) 2014.No additional information was provided.

Manufacturer Narrative

(b)(4).Part number changed from 1011721-33 to 1011709-33.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.

Manufacturer Narrative

(b)(4).Correction: the 'date received mfr' date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.

• Brand Name: XIENCE PRIME LL 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): CLONMEL, IRELAND REG# 9616693; 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: 7190577
• MDR Text Key: 97357743
• Report Number: 2024168-2018-00370
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2014
• Device Catalogue Number: 1011709-33
• Device Lot Number: 2082741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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
• Patient Age: 81 YR