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

Model Number H7493926238220

Device Problems Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent moved on balloon and device marking issue occurred.A 2.25 x 38 synergy¿ drug-eluting stent was selected to treat the lesion.However, upon removal of the protection sheath, the stent moved on the balloon.The device was not used and the procedure was completed with another of the same device.No patient injury or complications were reported.It was also noted that the lot number on the box was different to the lot number of the hub of the device.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that proximal stent rows 1 and 10 were damaged and the stent struts were lifted and pulled distally.The maximum crimped stent profile measurement at the time of manufacture was within specification.The tip was visually and microscopically examined and no issues were noted.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 and shaft polymer extrusion found no issues.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was not consistent with the complaint incident as stent movement was not evident during analysis.It was reported that the lot number indicated on the box #(b)(4) was different to the lot number indicated on the hub #(b)(4).A bottom up analysis of the finished goods batch (fgb) #(b)(4) was performed and no anomalies were noted.The fgb batch #(b)(4) indicated on the box is the finished goods batch number (fgb) after the stent has been crimped onto the sds whereas the catheter batch #(b)(4) present on the catheter is the catheter batch number.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that stent moved on balloon and device marking issue occurred.A 2.25 x 38 synergy¿ drug-eluting stent was selected to treat the lesion.However, upon removal of the protection sheath, the stent moved on the balloon.The device was not used and the procedure was completed with another of the same device.No patient injury or complications were reported.It was also noted that the lot number on the box was different to the lot number of the hub of the device.

• 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: 6549152
• MDR Text Key: 74592004
• Report Number: 2134265-2017-04445
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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: 02/06/2018
• Device Model Number: H7493926238220
• Device Catalogue Number: 39262-3822
• Device Lot Number: 19600736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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