PROMUS ELEMENT ¿ LONG

Report

Report Number: 2134265-2011-03208
Event Type: Malfunction
Date Received: August 4, 2011
Date of Event: July 15, 2011
Report Date: July 15, 2011
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE INNER OF THE LUMEN WAS KINKED AT SEVERAL LOCATIONS JUST DISTAL TO THE PORT. IN ADDITION, THE PORT REGION OF THE DEVICE WAS DAMAGED. THE BALLOON, STENT AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. A LARGE AMOUNT OF SOLIDIFIED BLOOD WAS PRESENT WITHIN THE BALLOON, THE ENTIRE LENGTH OF THE INFLATION LUMEN AND THE MANIFOLD, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. DURING PRODUCT ANALYSIS AT THE DEVICE WAS SOAKED IN WARM WATER IN AN ATTEMPT TO REMOVE THE SOLIDIFIED BLOOD. POST SOAKAGE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, A LEAK WAS NOTICED IN THE OUTER OF THE DEVICE. UPON FURTHER EXAMINATION OF THE DEVICE, A TEAR MEASURING APPROXIMATELY 12 MM IN LENGTH WAS PRESENT IN THE OUTER AT 266 MM PROXIMAL TO THE DISTAL TIP. AS A RESULT OF THIS, THE BALLOON OF THIS DEVICE WAS UNABLE TO BE INFLATED. 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

SAME CASE AS MDR# 2134265-2011-03209. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE 2.75X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE UNSPECIFIED LESION. PRIOR TO INFLATING THE DEVICE IT WAS NOTED THAT THERE WAS BLOOD IN THE INFLATOR. IT WAS SUSPECTED THAT A BALLOON RUPTURE OCCURRED. THE SDS WAS REMOVED AND A DIFFERENT 2.75X38MM PROMUS ELEMENT SDS WAS ADVANCED TO THE TARGET LESION. AGAIN, PRIOR TO INFLATING THE DEVICE IT WAS NOTED THAT THERE WAS BLOOD IN THE INFLATOR. IT WAS SUSPECTED THAT ANOTHER BALLOON RUPTURE OCCURRED. THE SDS WAS SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

Description of Event or Problem · 1

SAME CASE AS MDR# 2134265-2011-03209. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE 2.75X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE UNSPECIFIED LESION. PRIOR TO INFLATING THE DEVICE IT WAS NOTED THAT THERE WAS BLOOD IN THE INFLATOR. IT WAS SUSPECTED THAT A BALLOON RUPTURE OCCURRED. THE SDS WAS REMOVED AND A DIFFERENT 2.75X38MM PROMUS ELEMENT SDS WAS ADVANCED TO THE TARGET LESION. AGAIN, PRIOR TO INFLATING THE DEVICE IT WAS NOTED THAT THERE WAS BLOOD IN THE INFLATOR. IT WAS SUSPECTED THAT ANOTHER BALLOON RUPTURE OCCURRED. THE SDS WAS SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT ¿ LONG	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911338270	0013979341

Patients

Seq	Age	Sex	Outcome	Treatment
1