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	08/20/2018
Type of Reportable Event	Serious Injury
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 severely calcified left main artery.A 2.50 x 12mm synergy drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent came off from the balloon.The stent was then retrieved using a snaring device and a 2.0mm balloon catheter.A 2.25x12mm, 2.5x20mm, 2.25x12mm and 2.25x16 were then deployed and the procedure was completed.No patient complications nor injuries were reported.
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 severely calcified left main artery.A 2.50 x 12mm synergy drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent came off from the balloon.The stent was then retrieved using a snaring device and a 2.0mm balloon catheter.A 2.25x12mm, 2.5x20mm, 2.25x12mm and 2.25x16 were then deployed and the procedure was completed.No patient complications nor injuries were reported.Synergy ii us mr 2.50 x 12mm stent delivery system (sds) was returned for analysis with a detached stent.No stent returned.The balloon was reviewed.There was no stent on the balloon.The balloon wings appeared relaxed from their original folded position suggesting that some positive pressure could have been applied however it was not possible to confirm this as the balloon folds may have been affected by handling during removal or packaging for return.Crimp markings were evident on the balloon wall indicating correct crimping and positioning of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found 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: 7878098
• Report Number: 2134265-2018-61013
• Device Sequence Number: 13482918
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2019
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0021862583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: Required Intervention