MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10617
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.After deploying a 5.00 x 12 mm synergy drug-eluting stent, the balloon ruptured.The stent was successfully implanted.The catheter was completely removed from the patient's body and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.A synergy ii us mr 5.00 x 12mm stent delivery system was returned for analysis.The stent was not returned with the device as it was deployed during the procedure.The balloon cones showed signs of positive pressure applied.A red-ish blood-like substance was visible inside the balloon.A visual and microscopic examination of the bumper tip found distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the length of the hypotube.A visual examination of the outer and inner lumen and mid-shaft section found a shaft polymer extrusion break, on the proximal side of the port bond, located 119cm distal to the distal strain relief.The shaft polymer extrusion was stretched by approximately 4mm on the distal side of the port bond.Inner shaft polymer extrusion damage (bunching) 3mm distal to the bi-component bond.A recommended 0.0140 inch guidewire could not track past the inner shaft polymer extrusion damage via the tip.To facilitate a balloon inflation test, the shaft polymer extrusion was cut 3cm distal of the break site a needle was inserted in to the inflation lumen and the device was inflated to 16atm with no issues noted.A vacuum was pulled and the balloon deflated within specification.The inflation device was verified before and after use.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.After deploying a 5.00 x 12mm synergy drug-eluting stent, the balloon ruptured.The stent was successfully implanted.The catheter was completely removed from the patient's body and the procedure was completed.No patient complications were reported.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8687809
• Report Number: 2134265-2019-06351
• Device Sequence Number: 2319382
• Product Code: NIQ
• UDI-Device Identifier: 08714729973423
• UDI-Public: 08714729973423
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 11/04/2020
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0022901575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1