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

Model Number	10604
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent deformation had been present.A percutaneous coronary intervention of the distal circumflex was being performed.A 2.25 x 24 synergy drug-eluting coronary stent system was being used, but was unable to be delivered to the targeted area.It was noted that it looked like there was deformation on the un-deployed stent.The system was removed from the patient and a different device was used to successfully complete the procedure.There were no further issues or patient injuries.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 2.25 x 24mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found damage to the stent.The proximal end of the stent was damaged with stent struts bunched in a distal direction.The undamaged crimped stent od(outer diameter) was measured and the result was within max 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 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.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent deformation had been present.A percutaneous coronary intervention of the distal circumflex was being performed.A 2.25 x 24 synergy drug-eluting coronary stent system was being used, but was unable to be delivered to the targeted area.It was noted that it looked like there was deformation on the undeployed stent.The system was removed from the patient and a different device was used to successfully complete the procedure.There were no further issues or patient injuries.

• 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: 8171609
• Report Number: 2134265-2018-64108
• Device Sequence Number: 1501787
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/29/2019

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: 04/10/2019
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022035056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR