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

Model Number	10606
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break and stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.50 x 32 mm synergy stent was advanced to treat the lesion.However, the shaft broke during advancing and upon pulling the device out from the guide, it was noticed that the stent was no longer on the balloon.The stent was never found and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break and stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.50x32mm synergy stent was advanced to treat the lesion.However, the shaft broke during advancing and upon pulling the device out from the guide, it was noticed that the stent was no longer on the balloon.The stent was never found and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the shaft break occurred "halfway" from the hub.It is unknown exactly when the stent dislodged.The stent was not pulled into the guide catheter.The guide catheter was checked for the dislodged stent but it was not there.A scan was done on the patient to find the detached stent but was unable to be located.No further intervention was performed to locate the stent.
Event or Problem Description
It was reported that shaft break and stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.50x32mm synergy stent was advanced to treat the lesion.However, the shaft broke during advancing and upon pulling the device out from the guide, it was noticed that the stent was no longer on the balloon.The stent was never found and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the shaft break occurred "halfway" from the hub.It is unknown exactly when the stent dislodged.The stent was not pulled into the guide catheter.The guide catheter was checked for the dislodged stent but it was not there.A scan was done on the patient to find the detached stent but was unable to be located.No further intervention was performed to locate the stent.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 32mm stent delivery system was returned for analysis in broken into 2 sections without a stent.No stent returned.The balloon cones were reviewed and no issues were noted.The balloon wings were wrapped and folded and did not appears to have been subjected to positive pressure.A visual and tactile examination of the hypotube identified a hypotube break 22cm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the shaft polymer extrusion found that damage to the distal inner shaft (appeared to have been stretched and pinched) at a site 9cm proximal from the distal tip.A visual and microscopic examination of the tip identified no issues.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: 8831070
• Report Number: 2134265-2019-08136
• Device Sequence Number: 16661685
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 09/24/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023638591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 09/05/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/14/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other