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

Model Number 10606

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that device contamination occurred.A 3.00x32mm synergy drug-eluting stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.00 x 32 mm stent delivery system was returned for analysis in a biohazard bag.The device was inspected pre/decontamination and no visible foreign material could be noted.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent 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 visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube shaft found multiple hypotube kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that device contamination occurred.A 3.00x32mm synergy drug-eluting stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient was stable.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9395733
• MDR Text Key: 174580731
• Report Number: 2134265-2019-14197
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023870629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1