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

Model Number 10622

Device Problems Device Markings/Labelling Problem (2911); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage and labelling issue occurred.A 3.00x32mm synergy drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted and that the system batch number was different from the real batch number.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage and labelling issue occurred.A 3.00x32mm synergy drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted and that the system batch number was different from the real batch number.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.Synergy ous mr 3.00 x 32mm stent delivery system (sds) was received for analysis.An examination of the crimped stent identified damage to the midsection of the stent with struts lifted in a distal direction.The proximal and distal portions of the stent were undamaged.The undamaged crimped stent outer diameter was measured and the result was within the specification.The balloon cones were reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded.A visual and tactile examination of the hypotube identified no issues.An examination of the shaft polymer extrusion found no issues.There were no signs of damage or strain to the port bond.The tip was visually examined and no issues were noted.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7844498
• MDR Text Key: 119156272
• Report Number: 2134265-2018-60674
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 09/08/2019
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0021919403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1