FDA Adverse Event Malfunction Summary report: N

AXIOS

MDR report key: 20780460 · Received November 26, 2024

Report

Report Number: 3005099803-2024-05987
Event Type: Malfunction
Date Received: November 26, 2024
Date of Event: November 1, 2024
Report Date: November 25, 2024
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: KNS
UDI-DI: 08714729951179
PMA / PMN Number: K163272
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318 G4; REPORTED HERE AS THE PREMARKET #CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.

Description of Event or Problem · 0

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED, BUT IT DID NOT EXPAND. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2575704	AXIOS	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC CORPORATION	M00553660		08714729951179

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Prefer Not To Disclose