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

Lot Number 0026812055

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated by mfr: a partial stent delivery system was returned for analysis.Part of proximal shaft was returned for analysis.No manifold was returned with the device.Because the manifold/hub was broken off the hypotube the inflation test was done via attaching the inflation device onto the broken hypotube using inflation aid.Questions regarding how and when was it broken and if it will be returned to cis were asked, however no further information has been received.Examination of the crimped stent via scope found evidence of stent damage in proximal to mid region with struts bunched distally.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon was reviewed, and it was found to be in a partially deflated state with blood like substance visible.A pinhole was visible under microscopic inspection during inflation attempts.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues.Encore device verified before and after use using the druck gauge to 18 atm.Device attempted to be inflated to rbp 18 atm however pressure could not be maintained in the inflation device due to leak at the distal balloon cone.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture occurred.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15018643
• MDR Text Key: 303739781
• Report Number: 2134265-2022-07911
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Lot Number: 0026812055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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