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

Model Number	10603
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
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 as located in the severely tortuous and calcified left anterior descending artery.A 2.50x20mm synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to be delivered.When it was removed from the patient's body, it was noticed that the proximal edge of the stent struts were damaged.Another stent of the same sized was advanced to the lesion.Subsequently, a 1.2mm x 12mm threader balloon catheter was advanced but it failed to cross the lesion.Another 15mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The physician grabbed another balloon and completed the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 20 stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent identified stent damage with the distal struts stretched over distal marker band.The proximal end of the stent showed no sign of movement on the balloon as it appeared to be crimped in position.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found tip damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion as located in the severely tortuous and calcified left anterior descending artery.A 2.50x20mm synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to be delivered.When it was removed from the patient's body, it was noticed that the proximal edge of the stent struts were damaged.Another stent of the same sized was advanced to the lesion.Subsequently, a 1.2mm x 12mm threader balloon catheter was advanced but it failed to cross the lesion.Another 15mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The physician grabbed another balloon and completed the procedure.No patient complications were reported and the patient's status 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: 8429520
• Report Number: 2134265-2019-02617
• Device Sequence Number: 1628382
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/23/2019

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: 06/25/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0022329837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1