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

Model Number	10601
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).Device is a combination product.
Event or Problem Description
It was reported taht stent damage occurred.The target lesion was located in the right coronary artery.A 2.25 x 12mm synergy ii drug-eluting stent was advanced for treatment.However, when trying to place the stent in the artery, it was observed that the proximal end of the stent was damaged.The stent stayed intact with the balloon and was removed safely from the patient's body.The physician felt that the stent damage occurred when trying to advance it through a previously placed stent.The procedure was completed with another 2.25 x 12mm synergy ii drug-eluting stent with the assistance of using a guidezilla extension guide catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 12 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with struts on the distal end in a lifted state and stretched 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 signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues.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 the right coronary artery.A 2.25 x 12mm synergy ii drug-eluting stent was advanced for treatment.However, when trying to place the stent in the artery, it was observed that the proximal end of the stent was damaged.The stent stayed intact with the balloon and was removed safely from the patient's body.The physician felt that the stent damage occurred when trying to advance it through a previously placed stent.The procedure was completed with another 2.25 x 12mm synergy ii drug-eluting stent with the assistance of using a guidezilla extension guide catheter.No patient complications were reported.

• 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: 8905559
• Report Number: 2134265-2019-09836
• Device Sequence Number: 2267499
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/04/2019

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: 05/12/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023839065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR