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

Model Number 10622

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); Reocclusion (1985)

Event Date 11/03/2018

Event Type  Death  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that the patient expired.Vascular access was obtained via the femoral artery.The target lesion was located in the severely tortuous left circumflex and left anterior descending artery.The patient had previously experienced a myocardial infarction.During the procedure significant resistance was encountered.Three synergy stents, a 3x32mm, 2.5x38mm and a 3x16mm, were deployed.Post implantation the patient became sick and the stents became occluded.The patient was unable to survive and expired.The cause of death was not reported.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8117441
• MDR Text Key: 128816648
• Report Number: 2134265-2018-63338
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0022165931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death