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

Model Number H7493926224300

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a foreign matter was found and stent moved on balloon.A 3.00xmm 24 synergy¿ drug-eluting stent was selected to treat the lesion.During preparation, a fibrous protrusion was found in the lateral direction from the center of the stent.When the fibrous protrusion was tried to be pulled, the stent moved back and forth.The main body of the stent was not lifted but it was suspected that there was dust in between the balloon and stent.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Synergy ous mr 3.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent revealed no damage.There were no signs of damage or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter of the undamaged section of the stent was measured and result is within specification.There was foreign material (fm) found between proximal struts 2 and 3.The fm was analysed using fourier transform infra-red spectroscopy (ftir).The spectrum produced was similar to that of a cellulose material such as a cotton fiber.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.The balloon was inflated to nominal 11atm and then to rated burst pressure 16atm with no issues.The stent was deployed with no issues.There was a medium resembling dried blood evident on the balloon.The balloon was deflated in 3 seconds with no issues, this time was within specification.The inflation device was verified before and after use.A visual and tactile examination of the hypotube found multiple kinks.An examination of the shaft polymer extrusion revealed a kink at approximately 25mm distal to the guidewire port.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were found.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a foreign matter was found and stent moved on balloon.A 3.00xmm 24 synergy¿ drug-eluting stent was selected to treat the lesion.During preparation, a fibrous protrusion was found in the lateral direction from the center of the stent.When the fibrous protrusion was tried to be pulled, the stent moved back and forth.The main body of the stent was not lifted but it was suspected that there was dust in between the balloon and stent.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6412108
• MDR Text Key: 70181461
• Report Number: 2134265-2017-02205
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2018
• Device Model Number: H7493926224300
• Device Catalogue Number: 39262-2430
• Device Lot Number: 19615155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1