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

Model Number 10632

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 2.5-3.75mmx43mm, eccentric, de novo target lesion containing a >45 and <90 degrees bend was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 48 synergy drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and when removed, the tip of the stent itself was found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13119296
• MDR Text Key: 283152784
• Report Number: 2134265-2021-16334
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027527210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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: BALLOON CATHETER: RYUREI 2.5X40, NC EMERGE 2.5X20; GUIDE CATHETER: TERUMO 6F IL3.5; GUIDEWIRE: TERUMO FLOOPY
• Patient Age: 82 YR
• Patient Sex: Female