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

Catalog Number 1011733-12

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

Patient Problems Anemia (1706); Hypersensitivity/Allergic reaction (1907); Weakness (2145)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Date of angiography has been estimated.Implant date has been estimated.Therapy date has been estimated.Concomitant medical products: stent: xience prime 2.5x28; resolute integrity 3.0x12.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.5x28mm xience prime referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that a 2.5x28mm xience prime rx stent and a 3.0x12mm non-abbott stent were implanted approximately 2 years ago in the mid left anterior descending artery in (b)(6) 2013 due to shortness of breath.Additionally, a 3.0x12mm xience prime stent was implanted in (b)(6) 2013 in the posterior lateral artery.The patient was being seen over several months and was symptomatic during that time period with bone marrow suppression (depression), weight loss, hypoproteinemia, loss in muscle strength, decreased platelet, macrocytic anemia, decreased cholinesterase and heart failure.The patient had a healthy appetite and no cancer was noted.The patient was taking macrolide (clarith) from ten years ago.It was suspected that the patients symptoms were caused by the confluence of drug eluting stent (des) stenting and the prescribed medication.Thus, the medication was stopped and symptoms became progressively worse.Reportedly the patient was receiving ongoing treatment beginning 20 years ago because of the hypertensive myocardial hypertrophy and bronchiectasis.

Manufacturer Narrative

(b)(4).A partial udi is being reported because the lot number was not provided.There was no reported device malfunction and the product was not returned.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.Anemia and hypersensitivity are listed in the xience prime everolimus eluting coronary stent systems instructions for use 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 issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).

• Brand Name: XIENCE PRIME 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: 5136156
• MDR Text Key: 27801519
• Report Number: 2024168-2015-05914
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011733-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• 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): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 65