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

Model Number	10605
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
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.A 3.5 x 28 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that the proximal part of the stent was unraveled.The device was completely removed from the patient's body along with the guidewire.The procedure was completed with a different synergy drug-eluting stent.No patient serious injury or adverse event were reported and patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.50 x 28 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was damaged the whole length.The stent outer diameter at the time of manufacture was 0.041", this is within maximum crimped stent profile measurement.Stent damage most likely occurred due to interaction between this returned stent and the guide liner.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 no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a right coronary artery.A 3.5 x 28 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that the proximal part of the stent was unraveled.The device was completely removed from the patient's body along with the guidewire.The procedure was completed with a different synergy drug-eluting stent.No patient serious injury or adverse event were reported and patient was fine.

• 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: 8302200
• Report Number: 2134265-2019-00740
• Device Sequence Number: 11088722
• Product Code: NIQ
• UDI-Device Identifier: 08714729840305
• UDI-Public: 08714729840305
• 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,Followup
• Report Date (Section B): 03/27/2019

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: 07/10/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022418565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1