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

Model Number	10607
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 2.25 x 38 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found evidence of damage, with the first proximal strut lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within 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 no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 13mar2019.It was reported that shaft kink occurred.A 2.25x38 synergy drug-eluting stent was advanced for treatment.However, during delivery, a kink was noted in the catheter part of the delivery system.The procedure was completed with another 2.25x38 synergy drug-eluting stent.There were no patient complications reported.However, returned device analysis revealed stent damage.

• 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: 8479667
• Report Number: 2134265-2019-03311
• Device Sequence Number: 16570205
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/03/2019

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: 10/16/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022847475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1