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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  Death  

Event Description

It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.The procedure was to treat a lesion in the lad was 90% stenosed.During the deployment of the 3.00 x 28mm synergy xd coronary drug-eluting stent the stent did not fully expand resulting in post dilation was needed with the stent delivery balloon.Poor expansion was still observed.The stent was re-inflated a second time with negative pressure applied multiple times however the stent balloon remained inflated.While attempting to remove the stent balloon the shaft detached and was withdrawn from out of the sheath with the balloon remaining in the lad.During removal of the sds the shaft detached.A snare was unsuccessful to retrieve the detached shaft.A non-bsc guidewire crossed the distal to the balloon with attempts to obtain rail with a 2.5x12mm and 2.0x12mm balloon.A guide catheter was utilized to cover the undeflated balloon in an attempt to salvage.With the attempts, timi iii flow was established in the lad with a proximal dissection.Another synergy xd stent was placed.Patient was on non-bsc percutaneous heart pump and medication was administered.The patient passed away.

Manufacturer Narrative

B2: date of death (b)(6) 2021.Media analysis: the device associated with this complaint was not received for analysis.Photo images attached to the associated complaint ((b)(4)) could not be accessed for review.Received under the associated complaint ((b)(4)) was procedural media.A request was made through (b)(4) for medsafety to review.The assessment of this review will be captured under complaint (b)(4).If the review alters the conclusion for this complaint, this investigation will be re-opened and updated.

Event Description

It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.The procedure was to treat a lesion in the lad was 90% stenosed.During the deployment of the 3.00 x 28mm synergy xd coronary drug-eluting stent the stent did not fully expand resulting in post dilation was needed with the stent delivery balloon.Poor expansion was still observed.The stent was re-inflated a second time with negative pressure applied multiple times however the stent balloon remained inflated.While attempting to remove the stent balloon the shaft detached and was withdrawn from out of the sheath with the balloon remaining in the lad.During removal of the sds the shaft detached.A snare was unsuccessful to retrieve the detached shaft.A non-bsc guidewire crossed the distal to the balloon with attempts to obtain rail with a 2.5x12mm and 2.0x12mm balloon.A guide catheter was utilized to cover the undeflated balloon in an attempt to salvage.With the attempts, timi iii flow was established in the lad with a proximal dissection.Another synergy xd stent was placed.Patient was on non-bsc percutaneous heart pump and medication was administered.The patient passed away.It was further reported that the patient expired a few hours post procedure.The medical examiner chose not to conduct an autopsy so the cause of the bleeding and cause of death is unknown.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13017885
• MDR Text Key: 282329048
• Report Number: 2134265-2021-15885
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 98 KG