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

Model Number	10604
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used the first date of the month of the aware date as no event date was provided.Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 24mm stent delivery system was returned for analysis with a separated stent.A stent was returned separated from the delivery catheter.The stent was stretched and damaged.The proximal and distal ends of the stent were not as damaged as the mid-section and the stent struts could be seen to be in a crimped formation and therefore the stent did not appear to have been expanded.There was no stent on the balloon.The balloon was reviewed, and no damage noted to the balloon.The balloon was folded with crimp markings evident on the balloon body.The balloon had not been inflated.A visual and tactile examination found multiple hypotube kinks.Examination of the shaft polymer extrusion found no issues.Examination of the tip found tip damage.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 20-nov-2019.It was reported that crossing difficulties were encountered.A 4.00 x 24mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were 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: 9416889
• Report Number: 2134265-2019-15053
• Device Sequence Number: 2491464
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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 Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023682826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1