PROMUS ELEMENT ? LONG

Report

Report Number: 2134265-2014-02620
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: March 24, 2014
Report Date: April 18, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: A VISUAL AND TACTILE EXAMINATION OF THE MID-SHAFT SECTION FOUND A KINK AT THE MID-SHAFT BOND. THE OUTER SECTION OF THE SHAFT WAS BROKEN 160MM DISTAL FROM THE PORT BOND SKIVE. DISTALLY TO THIS BREAK THE UNIT WAS NOT RETURNED FOR ANALYSIS. THIS PART OF THE DEVICE WOULD CONTAIN THE BALLOON, CRIMPED STENT AND BUMPER TIP. AS A CONSEQUENCE OF THIS, DEVICE ANALYSIS COULD NOT DETERMINE THE CONDITION OF THIS PART OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN 2 SEPARATE LOCATIONS IN THE REGION OF THE SEVERE KINKING. THE FIRST HYPOTUBE BREAK 222MM DISTAL FROM STRAIN RELIEF. THE SECOND HYPOTUBE BREAK 885MM DISTAL FROM STRAIN RELIEF. THE HYPOTUBE MAY HAVE BROKEN DUE TO THE APPLICATION OF EXCESSIVE FORCE WHICH MAY HAVE INITIALLY KINKED THE DEVICE AND THEN RESULTED IN THE HYPOTUBE BREAKING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/ PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT SHAFT FRACTURE AND STENT DAMAGE OCCURRED. THE 80% STENOSED ECCENTRIC, DE NOVO 30MM X 3.0MM LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) AND IN THE DIAGONAL ARTERY. FOLLOWING PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A NON BSC STENT WAS IMPLANTED TO TREAT THE LAD LESION. SUBSEQUENTLY, A 3.00X38MM PROMUS ELEMENT LONG DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE DIAGONAL LESION. WHEN THE STENT REACHED THE DIAGONAL LESION, THE PHYSICIAN SLIGHTLY WITHDREW IT AND IT WAS NOTED THAT THE PROXIMAL 10MM FROM THE STENT WAS EXTRUDED. EVENTUALLY, THE PHYSICIAN TRIED TO WITHDREW THE STENT BUT IT WAS NOTICED THAT THE SHAFT FRACTURED ABOUT 20 CM FROM THE HUB OUTSIDE THE PATIENT. THE PHYSICIAN USED THE CATHETER TO WITHDREW THE STENT. THE DEVICE WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT SHAFT FRACTURE AND STENT DAMAGE OCCURRED. THE 80% STENOSED ECCENTRIC, DE NOVO 30MM X 3.0MM LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) AND IN THE DIAGONAL ARTERY. FOLLOWING PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A NON BSC STENT WAS IMPLANTED TO TREAT THE LAD LESION. SUBSEQUENTLY, A 3.00X38MM PROMUS ELEMENT ¿ LONG DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE DIAGONAL LESION. WHEN THE STENT REACHED THE DIAGONAL LESION, THE PHYSICIAN SLIGHTLY WITHDREW IT AND IT WAS NOTED THAT THE PROXIMAL 10MM FROM THE STENT WAS EXTRUDED. EVENTUALLY, THE PHYSICIAN TRIED TO WITHDREW THE STENT BUT IT WAS NOTICED THAT THE SHAFT FRACTURED ABOUT 20 CM FROM THE HUB OUTSIDE THE PATIENT. THE PHYSICIAN USED THE CATHETER TO WITHDREW THE STENT. THE DEVICE WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291840	PROMUS ELEMENT ? LONG	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911338300	16349960

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR