MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10601
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the mid right coronary artery.After a non-bsc guide extension catheter was placed, a 3.00 x 12 synergy drug-eluting stent was advanced to treat the lesion.However, the stent dislodged from the balloon inside the guide extension catheter.The wire, stent, guide extension catheter, was then removed from the body all at the same time and the stent was found inside the guide extension catheter.No patient complications were reported and the procedure was completed by stenting successfully the distal, mid, and proximal rca with a different device.Synergy ii us mr 3.00 x 12mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that the stent had detached from the sds and was severely damaged the whole length and bunched.The crimped stent od (outer diameter) at the time of manufacture was within maximum crimped stent profile measurement.A visual examination of the bumper tip showed no signs of damage.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp stent markings were visible on the balloon body which is an indication that the stent was crimped on the balloon prior stent to detachment.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage most likely occurred due to excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7922293
• Report Number: 2134265-2018-61458
• Device Sequence Number: 16555005
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0021662553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR