MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926220250

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

Patient Problems Rash (2033); Skin Irritation (2076); Toxemia (2207)

Event Date 10/23/2017

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.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-12192.It was reported that skin issues occurred.In (b)(6) 2017, a patient underwent a repeat coronary angiography for stenosis.2.5 x 8 and 2.5 x 20 synergy drug eluting stents were implanted.Iodixanol radiocontrast was used during the procedure.In (b)(6) 2017, the patient presented with an erythematous non-pruriginous rash evocative of toxidermia, affecting the trunk, the limbs, respecting the face, with no mucosal injury.A biopsy was consistent with the proposed diagnosis of toxidermia.Testing was performed and then an iodinated contrast product was introducted.There was initial improvement of the rash and hypereosinophilia and after that the rash and hypereosinophilia reoccurred.The rash has evolved towards the persistence of some eczematiform lesions in the lower back.The hypereosinophilia has regressed.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the physician did not know if the skin reaction occurred because of the synergy stent.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 7108326
• MDR Text Key: 94512929
• Report Number: 2134265-2017-12193
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493926220250
• Device Catalogue Number: 39262-2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• 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
• Treatment: CONTRAST AGENT: VISIPAQUE
• Patient Outcome(s): Required Intervention