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

Model Number H7493926216270

Device Problems Hole In Material (1293); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that balloon pinhole and inadequate stent apposition occurred.The target lesion was located in the left anterior descending artery.A 2.75 x 16 synergy¿ drug-eluting stent was advanced to treat the lesion.However, upon deployment at 12 atmospheres, the device would not hold inflation pressure.The stent was deployed and the stent delivery system was removed and a hole was noted on the balloon.Subsequently, a non-compliant balloon was used to further expand the stent to full apposition and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: synergy ous, mr, 2.75 x 16mm stent delivery system (sds) was returned for analysis.The stent was not returned for analysis with the device as it was deployed during the procedure.A visual examination found solidified media and blood noted inside the balloon chamber, positive pressure appeared to have been applied to the balloon.An attempt was made to inflate the device to 18atm however; this was not possible due to the solidified media.The device was left soaking in the waterbath.A pinhole leak was identified 8mm proximal of the proximal edge of the distal markerband.The inflation device was verified at 18 atmospheres (atm) before and after use with a calibrated pressure.The batch crimping records did not highlight any anomalies with the stent profile that could have contributed to balloon damage during the manufacturing process.There was no apparent damage or issues noted to the balloon wall no issues that could have potentially contributed to the complaint incident.A visual and tactile examination found slight hypotube kinks along the full catheter length.A visual and tactile examination found no issue with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found slight damage to the tip.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 balloon pinhole and inadequate stent apposition occurred.The target lesion was located in the left anterior descending artery.A 2.75 x 16 synergy¿ drug-eluting stent was advanced to treat the lesion.However, upon deployment at 12 atmospheres, the device would not hold inflation pressure.The stent was deployed and the stent delivery system was removed and a hole was noted on the balloon.Subsequently, a non-compliant balloon was used to further expand the stent to full apposition and the procedure was completed.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: 6037731
• MDR Text Key: 57773550
• Report Number: 2134265-2016-09048
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2017
• Device Model Number: H7493926216270
• Device Catalogue Number: 39262-1627
• Device Lot Number: 18780117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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
• Patient Outcome(s): Required Intervention