MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926028220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 2.25 x 28mm synergy ii drug-eluting stent was selected for use.However, resistance was encountered upon loading the device on the wire.When the physician used a little bit more force, the device started to load; however, it was noted that the stent strut was bent.The device was pushed a little bit harder and it was noted that it kind of folded a little bit with the stent still on the balloon.The device was removed and the procedure was completed with a 2.5x28mm stent.No patient complications were reported.

Manufacturer Narrative

Describe event or problem, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes: updated.Device evaluated by mfr.: synergy ii us mr 2.25 x 28mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.Strut rows 7, 8, 13 and 14 from the distal end of the stent were misaligned.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was within max 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 tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.There were no issues advancing the device over a 0.014¿ guidewire.The tip was visually and microscopically examined and damage was noted.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was further reported that the physician had difficulties loading the wire.When the wire entered the stent, advancing difficulties were encountered and the wire was removed.The device was wiped with a wet gauze and reinserted at about 5-10mm; but still had the same issue two times.The physician used a little more force and the device loaded; however, it was noted that the stented portion of the stent delivery system (sds) bent which caused the visible disruption of the undeployed stent.The physician straightened the sds but was asked to replace with another stent for patient's safety.The devices were never inside the body when the issue happened.

Event Description

It was further reported that the physician had difficulties loading the wire.When the wire entered the stent, advancing difficulties were encountered and the wire was removed.The device was wiped with a wet gauze and reinserted at about 5-10mm; but still had the same issue two times.The physician used a little more force and the device loaded; however, it was noted that the stented portion of the stent delivery system (sds) bent which caused the visible disruption of the undeployed stent.The physician straightened the sds but was asked to replace with another stent for patient's safety.The devices were never inside the body when the issue happened.

Manufacturer Narrative

Device evaluated by mfr.: synergy ii us mr 2.25 x 28mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.Strut rows 7, 8, 13 and 14 from the distal end of the stent were misaligned.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was within max 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 tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.There were no issues advancing the device over a 0.014¿ guidewire.The tip was visually and microscopically examined and damage was noted.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7588592
• MDR Text Key: 110671349
• Report Number: 2134265-2018-05309
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 11/01/2018
• Device Model Number: H7493926028220
• Device Catalogue Number: 39260-2822
• Device Lot Number: 0021365350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1