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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926216270
Device Problems Balloon; Stent; Hole In Material; Activation, Positioning or Separation Problem
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.

 
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Brand NameSYNERGY¿
Type of DeviceCORONARY 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 Key6037731
Report Number2134265-2016-09048
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received10/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/18/2017
Device MODEL NumberH7493926216270
Device Catalogue Number39262-1627
Device LOT Number18780117
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/18/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/18/2016 Patient Sequence Number: 1
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