FDA Adverse Event Malfunction Summary report: N

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

MDR report key: 1800054 · Received August 11, 2010

Report

Report Number: 2953200-2010-01522
Event Type: Malfunction
Date Received: August 11, 2010
Date of Event: June 3, 2010
Report Date: July 15, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: NIQ
PMA / PMN Number: P060033
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: ROOT CAUSE FOR CATHETER DAMAGE CANNOT BE DETERMINED. STENT DEFORMATION. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE RELEVANT DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE HYPOTUBE WAS BENT, WAVY AND KINKED 5CM AND 61.5CM DISTAL TO THE STRAIN RELIEF. THE STENT WAS ON THE BALLOON. THE FIRST DISTAL STENT SEGMENT HAD MOVED TO PARTIALLY OVERLAP BOTH THE DISTAL MARKER BAND. THE MIDDLE PORTION OF THE STENT WAS SLIGHTLY STRETCHED. THERE WAS A TEAR OF THE OUTER AND INNER SHAFT JUST DISTAL TO THE GUIDE WIRE ENTRY PORT. THERE WERE CHATTER MARKS ALONG THE DISTAL SHAFT. THE GUIDE WIRE ENTRY PORT, DISTAL OUTER AND INNER SHAFT WERE SEVERELY TORN WITH A CHATTER MARK EFFECT 1.5CM DISTALLY ALONG THE SHAFT. NEGATIVE PURGE DID CONFIRM THE PRESENCE OF A LEAK, THE DEVICE WAS INFLATED AND LIQUID WAS SEEN LEAKING FROM THE TORN DISTAL SHAFT.

Description of Event or Problem · 1

AN ATTEMPT WAS MADE TO DEPLOY A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) IN TO A PATIENT. HOWEVER, IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE. NO CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDEAVOR SPRINT RX CORONARY STENT SYSTEM		NIQ	MEDTRONIC CARDIOVASCULAR GALWAY	NA	0001322053

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK