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

Model Number 10622

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Remove (1528); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent deployment, entrapment and difficulty removing occurred.The target lesion was located in the mid left anterior descending artery.During deployment of a 2.75 x 32mm synergy ii drug eluting stent, the device got stuck and during retrieval with the wire, the wire got stretched.Snaring was then used to retrieve the wire together with the stent.The procedure was completed with another device.There were no patient complications reported.

Event Description

It was reported that stent deployment, entrapment and difficulty removing occurred.The target lesion was located in the mid left anterior descending artery.During deployment of a 2.75 x 32mm synergy ii drug eluting stent, the device got stuck and during retrieval with the wire, the wire got stretched.Snaring was then used to retrieve the wire together with the stent.The procedure was completed with another device.There were no patient complications reported.It was further reported the stent was deployed in the mid lad which was previously reported as deployment issues.When the physician went to remove the guidewire and the synergy delivery system from the lesion, resistance occurred.The physician continued to pull the guidewire and it stretched.To avoid breaking the guidewire, the physician decided to use a snare for removal.When the guidewire was removed using the snare, the deployed synergy stent was also removed together and found stretched after removal.

Manufacturer Narrative

Correction has been made to the device codes.B5 describe event or problem - correction has been made along with additional information added.Device is a combination product.

Event Description

It was reported that stent deployment, entrapment and difficulty removing occurred.The target lesion was located in the mid left anterior descending artery.During deployment of a 2.75 x 32mm synergy ii drug eluting stent, the device got stuck and during retrieval with the wire, the wire got stretched.Snaring was then used to retrieve the wire together with the stent.The procedure was completed with another device.There were no patient complications reported.It was further reported the stent was deployed in the mid lad which was previously reported as deployment issues.When the physician went to remove the guidewire and the synergy delivery system from the lesion, resistance occurred.The physician continued to pull the guidewire and it stretched.To avoid breaking the guidewire, the physician decided to use a snare for removal.When the guidewire was removed using the snare, the deployed synergy stent was also removed together and found stretched after removal.

Manufacturer Narrative

Correction has been made to the device codes.B5 describe event or problem - correction has been made along with additional information added.Device is a combination product.Device evaluated by mfr.: the device was returned for analysis.A severely damaged stent was returned for analysis attached to a 0.014 inch non-bsc guidewire and a snare.The outer spindles of the guidewire appear unravelled and connected to the snare.The entire length of the stent was stretched and entangled on the non-bsc guidewire.The stent delivery system was not returned for analysis, so these profiles could not be analysed.No other issues were noted with the returned stent.

• 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: 9496429
• MDR Text Key: 172067194
• Report Number: 2134265-2019-15998
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024161129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 01/30/2020
• Supplement Dates FDA Received: 01/06/2020; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention