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

Catalog Number 1011732-38

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 07/23/2013

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, three stents were implanted.A 3.0x28mm xience prime was implanted in the proximal to mid left anterior descending artery.A non-abbott stent was implanted in the distal circumflex.After pre-dilatation was performed a 2.75x38 mm xience prime was implanted in the posterior lateral artery.On (b)(6) 2012, the patient was discharged from hospital.On (b)(6) 2013, the patient developed stable angina and in-stent restenosis of the 2.75x38 mm xience prime stent in the posterior lateral was confirmed on angiography.No treatment was performed.On (b)(6) 2014, revascularization was performed to treat the lesion and the stenosis was reduced from 99% to 0% after dilatation with a balloon catheter.On (b)(6) the symptoms had resolved.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Stenosis, angina and prolonged hospitalization are listed in the xience prime everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Although 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 deficiency with respect to manufacturing, design or labeling.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4354164
• MDR Text Key: 5221329
• Report Number: 2024168-2014-08422
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2013
• Device Catalogue Number: 1011732-38
• Device Lot Number: 2042541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Treatment: STENT: 3.0X28MM XIENCE PRIME, BSC PROMUS ELEMENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60