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

Model Number	10602
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used (b)(6) 2019, the first day of the month of the aware date as no exact date provided.A synergy ii us mr 2.50 x 16 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of distal stent damage with struts lifted.The undamaged crimped stent od (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 blood-like substance was visible inside the balloon and lumen.A visual and microscopic examination of the bumper tip showed signs of damage and solidified clear contrast-like substance was visible on the tip and stent.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found the outer shaft and port bond site were torn 120.4 cm distal to the distal end of the strain relief.The tear was 6mm in length.The device was soaked at 37 degrees celsius to loosen the solidified clear media on the device.The inflation device was verified.A recommended 0.014 test guidewire was loaded without issue.The balloon was unable to inflate due to a leak at the site of the shaft tear.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 04dec2019.It was reported that balloon inflation failure occurred.The target lesion was located in the tightly tortuous proximal circumflex artery.A 2.50 x 16 synergy ll drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the balloon would not inflate in the lesion.The procedure was completed with another of the same device.There were no patient complications reported and patient is doing well post procedure.However, returned device analysis revealed stent damage and shaft tear.

• 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: 9455672
• Report Number: 2134265-2019-15319
• Device Sequence Number: 3040212
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 12/11/2019

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: 06/09/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023951331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR