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

Model Number	10607
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 38mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage; the proximal end of the stent was bunched in a distal direction along the balloon.The undamaged crimped stent outer diameter was measured 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.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found a hypotube break 23.5cm distal to distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that shaft break occurred.The target lesion was located in a highly calcified coronary artery.A 2.25 x 38 synergy drug-eluting stent was selected for use.However, the shaft broke inside the guide catheter less than15cm from the hub.The device was completely removed from the patient's body.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed hypotube fracture and 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: 8603690
• Report Number: 2134265-2019-05169
• Device Sequence Number: 2948166
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 01/20/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023236809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR