FDA Adverse Event Injury Summary report: N

WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

MDR report key: 3528732 · Received December 19, 2013

Report

Report Number: 2134265-2013-09068
Event Type: Injury
Date Received: December 19, 2013
Report Date: November 25, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: JCT
PMA / PMN Number: K003100
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

JOURNAL ARTICLE: ROCHA, LAURA, ET. AL. ¿ENDOVASCULAR APPROACH FOR PERIPHERAL ARTERIAL INJURIES,¿ ANNALS OF VASCULAR SURGERY, 27. 2013: 587¿593. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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).

Description of Event or Problem · 1

REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT GRAFT OCCLUSION OCCURRED. THE PATIENT HAD A PSEUDOANEURYSM IN THE RIGHT SUBCLAVIAN AFTER AN ARTERIAL PUNCTURE FOR A SEPARATE PROCEDURE. THE INJURY WAS TREATED WITH A 12X50MM WALLGRAFT AND A 13X100MM NON BSC GRAFT. A DUPLEX SCAN 6 MONTHS AFTER THE PROCEDURE SHOWED NO FLOW DISTURBANCES. HOWEVER, WITHIN ONE YEAR POST PROCEDURE, THE PATIENT PRESENTED WITH MILD ARM CLAUDICATION AND THE GRAFT WAS NOTED TO BE OCCLUDED. THEY HYPOTHESIZED THAT INTIMAL HYPERPLASIA WAS THE CAUSE OF OCCLUSION. AFTER THE RISKS OF A NEW OPEN OR ENDOVASCULAR INTERVENTION WERE DISCUSSED, THE PATIENT CHOSE TO BE TREATED CONSERVATIVELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
664733	WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	PROSTHESIS, TRACHEAL, EXPANDABLE	JCT	BOSTON SCIENTIFIC - GALWAY	UNK526

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Required Intervention