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

Model Number H7493926228400

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Age at time of event: 18 years or older.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a stent damage occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 4.00x28mm synergy drug-eluting stent was advanced to treat the target lesion.However, during delivery, resistance inside the guiding catheter was encountered and the device was unable to cross the lesion.When the device was removed together with the guiding catheter, the stent was found lifted.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that a stent damage occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 4.00x28mm synergy¿ drug-eluting stent was advanced to treat the target lesion.However, during delivery, resistance inside the guiding catheter was encountered and the device was unable to cross the lesion.When the device was removed together with the guiding catheter, the stent was found lifted.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: synergy ous mr 4.00 x 28mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Stent strut rows from distal end of stent to mid-section were lifted and bunched proximally.The crimped stent od (outer diameter) of the undamaged portion of the stent 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 tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination found 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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 4.00 x 28mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Stent strut rows from distal end of stent to mid-section were lifted and bunched proximally.The crimped stent od (outer diameter) of the undamaged portion of the stent 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 tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination found 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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that a stent damage occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 4.00x28mm synergy¿ drug-eluting stent was advanced to treat the target lesion.However, during delivery, resistance inside the guiding catheter was encountered and the device was unable to cross the lesion.When the device was removed together with the guiding catheter, the stent was found lifted.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7632643
• MDR Text Key: 112192512
• Report Number: 2134265-2018-05928
• 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
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: 03/18/2019
• Device Model Number: H7493926228400
• Device Catalogue Number: 39262-2840
• Device Lot Number: 21181346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/24/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1