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

Model Number	10602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a right coronary artery (rca) which had a tight turn.Following proximal stenting, two 2.25 x 16m drug-eluting stents (des) were advanced for treatment in the ostial posterior descending artery/postero lateral artery.Both devices failed to cross and the stent struts were noted to be flared upon removal.Another 2.25 x 16mm synergy des was advanced but the stent came off the balloon.A 3.5 synergy des was then placed past the proximal stents to trap the dislodged stent between the 3.5 and a previously implanted stent.The procedure was completed and no patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a right coronary artery (rca) which had a tight turn.Following proximal stenting, two 2.25 x 16m drug-eluting stents (des) were advanced for treatment in the ostial posterior descending artery/postero lateral artery.Both devices failed to cross and the stent struts were noted to be flared upon removal.Another 2.25 x 16mm synergy des was advanced but the stent came off the balloon.A 3.5 synergy des was then placed past the proximal stents to trap the dislodged stent between the 3.5 and a previously implanted stent.The procedure was completed and no patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.D4 lot number and expiration date corrected.H4 device manufacture date corrected.A synergy ii us mr 2.25 x 16 mm stent delivery system was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from the proximal stent region were noted to be lifted from their crimped position and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within the maximum crimped stent profile measurement.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 signs of distal tip damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.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: 9888679
• Report Number: 2134265-2020-03556
• Device Sequence Number: 14033072
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/19/2020

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: 04/16/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023684169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 3.5 SYNERGY; STENT: 3.5 SYNERGY