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

Model Number 10617

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problems Stenosis (2263); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that removal difficulty,stent dislodgement, vessel occlusion and stent damage occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal left anterior descending (lad) artery.After another manufactures drug-eluting stent was deployed in lad, a 2.50 x 12 synergy drug-eluting stent was advanced, but encountered a strong resistance and failed to cross the lesion.During removal the synergy stent was caught on the proximal edge of the other manufactures stent that was deployed in lad, the synergy stent dislodged and the lad became completely occluded.They attempted to remove the dislodged synergy stent with a snare, but failed.Surgical removal was then performed and was able to remove the synergy and other manufactures stent, and the snare device.The removed device was severely damaged.No further patient complications were 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10352663
• MDR Text Key: 201731169
• Report Number: 2134265-2020-09435
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0024359999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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