MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10601

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that shaft break occurred.The target lesion was located in a calcified vessel.A 2.50 x 12 synergy drug-eluting stent was deployed in a kissing stent fashion.The stent was deployed well but somehow became stuck underneath the other stent that was already placed and got pinned up against a stent strut and snapped off the hypotube of the stent balloon.A 3.50mm x 12mm nc emerge balloon catheter was then advanced, but was also pinned within the stent strut and snapped off as well.They used a snare to remove the device and patient was stable enough to move to intensive care unit (icu).

Event Description

It was reported that shaft break occurred.The target lesion was located in a calcified vessel.A 2.50 x 12 synergy drug-eluting stent was deployed in a kissing stent fashion.The stent was deployed well but somehow became stuck underneath the other stent that was already placed and got pinned up against a stent strut and snapped off the hypotube of the stent balloon.A 3.50mm x 12mm nc emerge balloon catheter was then advanced, but was also pinned within the stent strut and snapped off as well.They used a snare to remove the device and patient was stable enough to move to intensive care unit (icu).

Manufacturer Narrative

Device evaluated by mfr.: synergy ii us mr 2.50 x 12mm stent delivery system was returned for analysis.Partial device (1319mm in length) from proximal tip of manifold to guidewire port with exposed core wire returned.Distal section (including portion of distal shaft, balloon, stent and tip) not returned.A visual and tactile examination of the hypotube shaft found a hypotube lasercut region exposed with outer lumen coating removed 25 mm proximal to guidewire port (1226 distal to proximal end of manifold) and multiple kinks along the length of the shaft.A visual examination of the outer and inner lumen and mid-shaft section identified a break in the polymer extrusion region (within the trough/wire exchange port with exposed corewire) 1264mm distal to tip of the manifold.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10323607
• MDR Text Key: 200391647
• Report Number: 2134265-2020-09196
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention