TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2011-02761
Event Type: Injury
Date Received: July 13, 2011
Date of Event: May 27, 2011
Report Date: June 13, 2011
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE IS A COMBINATION PRODUCT - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE AT THE INDEX PROCEDURE THAT THE ANGIOGRAPHY SHOWED THE LAD HAD MILD 30% PROXIMAL NARROWING AND A HIGH GRADE 90% STENOSIS AT THE JUNCTION OF THE MIDDLE AND DISTAL THIRD. SUBTOTAL OCCLUSION OF THE MID THIRD TO DISTAL THIRD OF LAD. THE TARGET LESION LOCATED IN THE MID LAD WAS LOCATED WITHIN A PREVIOUSLY DEPLOYED DRUG ELUTING STENT. POST STENT DEPLOYMENT THERE WAS SOME SPASM DISTALLY WHICH WAS TREATED WITH NITROGLYCERIN WITH TIMI GRADE 3 FLOW. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. AT THE TIME OF THE EVENT, THE PATIENT UNDERWENT TREADMILL TESTING FOR THE EVALUATION OF CHEST PAIN. THE RESULTS WERE WITHIN NORMAL LIMITS WITH MINOR NON-SPECIFIC ST-T WAVE CHANGES FROM BASELINE WHICH NORMALIZED IMMEDIATELY INTO RECOVERY. IN (B)(6) 2011 THE PATIENT PRESENTED WITH HISTORY OF 2 WEEKS OF ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DISTAL EDGE RESTENOSIS WAS TREATED WITH PLACEMENT OF A 2.5 X 8 MM ION STENT. THERE WAS 20% NARROWING JUST BEFORE THE DEPLOYED STENT WHICH APPEARED AS 40-50% POST STENT PLACEMENT, PRESUMABLE DUE TO SPASM. THE PROXIMAL LAD WAS TREATED WITH PLACEMENT OF A 2.5X12MM ION STENT WITH RESIDUAL STENOSIS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TARGET LESION WAS LOCATED WITHIN A PREVIOUSLY PLACED STENT AND POST STENT DEPLOYMENT THERE WAS SOME SPASM DISTALLY WHICH WAS TREATED WITH NITROGLYCERIN.

Description of Event or Problem · 1

(B)(6). SAME PATIENT AS: 2134265-2011-02760. SAME PATIENT AS: 2134265-2010-03515, 2134265-2010-03516. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND RESTENOSIS. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 90% RESTENOSED, 2.25MM LONG AND 28MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.5X28MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. PRIOR TO THIS PROCEDURE THE PATIENT HAD A 2.25X28MM TAXUS LIBERTE STENT IMPLANTED IN THE MID LAD ON AN UNSPECIFIED DATE. IN (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN AND CARDIAC CATHETERIZATION WAS RECOMMENDED. IN (B)(6) 2011, THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION FOR A DISTAL EDGE RESTENOSIS OF THE TAXUS LIBERTE STENTS LOCATED IN THE MID LAD. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A DRUG ELUTING STENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	UNK433

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention