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

Model Number	10602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the right radial artery.The 70% stenosed target lesion was located in the non-tortuous proximal left anterior descending artery.After a 5f 3.75 nonbsc guide catheter was engaged over a nonbsc guide wire, a 2.75 x 16mm synergy stent was advanced to treat the lesion.However, when the length of the guide was imaged, it was noted that the stent delivery system had detached at the bisegmented portion of the catheter and the hypotube.The stent was subsequently removed via the guide catheter and wire.The devices was removed completely and the procedure was completed with a nonbsc stent.No patient complications no injuries were reported.Synergy ii us mr was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and met specification.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.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a hypotube break 638 mm distal from distal edge of strain relief, the distal portion of the hypotube was not returned for analysis.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a shaft extrusion break 68 mm proximal from distal edge of device tip (11mm proximal from bi-component bond), the proximal portion of the extrusion and mid-shaft not were returned for analysis.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: 7934281
• Report Number: 2134265-2018-61580
• Device Sequence Number: 1499862
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• 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
• Report Date (Section B): 10/04/2018

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: 11/20/2018
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0021448269
• 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: 09/10/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR