| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60 | PLATELET CONCENTRATE SYSTEM | HARVEST TECHNOLOGIES, CORP. | JQC | APC60 | APC60 | 863502-0023 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-05-24 | 0 | 1. O |
Patient 1
PATIENT WITH RIGHT KNEE PAIN AT 2 MONTHS WAS DIAGNOSED WITH DEGENERATIVE MENISCAL TEAR AND WAS TREATED WITH ARTHROSCOPIC DEBRIDEMENT FOLLOWED BY PRP INJECTION. FOLLOWING THE PROCEDURE PATIENT HAD PERSISTENT LEG EDEMA AND WAS CLINICALLY DIAGNOSED WITH DEEP VEIN THROMBOSIS.
Patient 1
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVIATIONS WERE NOTED. TWO ADVERSE EVENTS WERE REPORTED BY THE SAME SURGEON FOR THIS LOT OF PRODUCT. THE OTHER EVENT HAS BEEN REPORTED UNDER MDR NUMBER 1225520-2012-0002. ASIDE FROM THESE TWO REPORTED EVENTS, THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED AGAINST THIS LOT. IN ADDITION, WE HAVE HAD NO PRIOR REPORTS OF DVT FOR THE PRODUCT. HARVEST TECHNOLOGIES CONSULTED OUR CLINICAL ADVISOR AND QUERIED THE SITE TO PROVIDE MORE DETAILS CONCERNING PRE-EXISTING CONDITIONS OF THE PATIENT THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION REVEALED THAT A TOURNIQUET WAS USED DURING THE PROCEDURE AND THAT NO ANTICOAGULANT PROPHYLAXIS WAS ADMINISTERED. OUR MEDICAL ADVISOR, (B)(6), MD. CONFIRMED THAT ALTHOUGH THE SITE MENTIONED A "CLINICAL DIAGNOSIS OF DVT" AS AN ULTRASOUND WAS NEGATIVE FOR DVT, IT CAN BE CONCLUDED THAT NO DVT WAS PRESENT. HE CONFIRMED THAT EDEMA IS A KNOWN RISK OF ARTHROSCOPIC DEBRIDEMENT USING A TOURNIQUET. BASED ON A REVIEW OF THE AVAILABLE INFORMATION DR. (B)(4) PROVIDED THE FOLLOWING OPINION: "PATIENT (B)(6) HAD ARTHROSCOPIC DEBRIDEMENT OF A DEGENERATIVE MENISCUS AND DEVELOPED SWELLING. THE ULTRASOUND SHOWED NO EVIDENCE OF DEEP VENOUS THROMBOSIS. WITHOUT ANY EVIDENCE OF DVT THERE IS NO SUCH ENTITY AS "CLINICALLY DIAGNOSED" DEEP VENOUS THROMBOSIS. THE SWELLING IS MOST LIKELY RELATED TO THE ORTHOPEDIC PROCEDURE."