MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926038270

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

Patient Problems Dyspnea (1816); Rash (2033); Swelling (2091); Reaction (2414)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as: 2134265-2017-05228.It was reported that the patient experienced an allergic reaction.Two synergy¿ stents were implanted in a coronary artery.The following day the patient experienced a rash.The patient has also experienced throat swelling leading to an inability to breath, erratic heartbeat, hives and itching skin.The patient has been hospitalized 4 times since having the stents implanted with "severe reactions." the patient is taking steroids and multiple allergy medications for treatment.

Manufacturer Narrative

Age at time of event, age at time of event (unit), weight, weigh (unit), describe event or problem, upn, catalog/model #, device lot number, device expiration date, device manufactured date and udi number updated.(b)(4).

Event Description

It was further reported that the two stents implanted were 2.75 x 38 synergy ii devices and that the stents were implanted in the right coronary artery.In (b)(6) 2017, 5 days after the stents were implanted, the patient was seen in the emergency department for symptoms consistent with a tenia parasite or yeast infection.The patient was discharged with prescriptions for clotrimazole and nystatin.The following day the patient presented to a different emergency department and was admitted with rash, pruritus, dyspnea, feeling of throat face and eyes being swollen.He had been seen multiple times for this and had recently been treated with diphenhydramine, famotidine, and steroids with initial improvement in his symptoms but after he stopped the medications his symptoms returned.Cardiology was consulted.It was felt the most likely offending agent was prasugrel since his symptoms started after it was prescribed.Prasugrel was discontinued.Patient was given clopidogrel (600 mg ×1)and then started on 75 mg daily.His pruritus, rash, dyspnea and swelling all resolved.The patient was discharged home in stable condition to return if any worsening symptoms occur as discussed.Approximately 2 weeks later, the patient presented at the emergency department (ed) and was admitted for observation.The presenting symptoms were redness, itching and swelling of both hands, rash and feeling of throat and states swelling.Prednisone therapy was completed and stopped 2 days prior and the patient then developed hives, tongue and facial swelling and feeling like he cannot breathe with fullness in his chest.He was given iv steroids and diphenhydramine in the ed with much improvement.He was seen in consultation with cardiology.He was placed on prednisone 20 mg daily ×7 days then prednisone 10 mg daily until a follow-up in the office.The patient was also given hydroxyzine.The patient was instructed by cardiology to stop all medications except for aspirin, clopidogrel and prednisone.He was instructed to follow-up with outpatient date and allergy department to undergo allergy testing in hopes to desensitize patient.Patient was instructed to return to the ed for difficulty breathing or recurrent throat swelling.Patient was in agreement with discharge and plan and stable for discharge home.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6607819
• MDR Text Key: 76518904
• Report Number: 2134265-2017-05227
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2017
• Device Model Number: H7493926038270
• Device Catalogue Number: 39260-3827
• Device Lot Number: 20082751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• 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: 52 YR
• Patient Weight: 102