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

Model Number	10607
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon rupture, shaft detachment, and vessel dissection occurred.Vascular access was obtained via the right femoral artery.The target lesion was segmental with a series of calcified lesions located in the left anterior descending (lad) artery.The ostial lad was 95% stenosed.The mid to distal lad was calcified with 90% stenosis.The pre-interventional distal flow was normal (timi-3).A 2.25mmx38mm synergy ii drug elution stent was deployed but due to the heavily calcified lesions it was not fully expanded and the device shaft and balloon were detached and remained inside the lad, left main (lm), and aorta.The post-interventional distal flow was decreased (timi 2) and a dissection was noted.Attempts to wire past the obstructing device fragments were unsuccessful.In order to protect the lm, a 7 fr guide was inserted from the left femoral artery and wired the left main to circumflex coronary artery (lcx).The right femoral 6 fr guide was removed.A 10 mm snare was used to successfully snare most of the detached shaft out of the body.It was uncertain how much of the detached shaft remained.The lm to the ostial lcx was successfully stented with a 4x16 synergy ii drug eluting stent to stent any remaining parts to the vessel wall.The patient remained asymptomatic and hemodynamically stable during the procedure.

• 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: 7992701
• Report Number: 2134265-2018-62124
• Device Sequence Number: 1255850
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/22/2018

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: 01/31/2019
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0021724153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/22/2018
• 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
• Patient Age: 83 YR