MYNX VASCULAR CLOSURE DEVICE

Report

Report Number: 3004939290-2011-00145
Event Type: Injury
Date Received: July 8, 2011
Date of Event: June 7, 2011
Report Date: June 9, 2011
Manufacturer: ACCESSCLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION RECEIVED AND WITH NO DEVICE RETURNED, THE CAUSE OF THE REPORTED BALLOON LOSS OF PRESSURE COULD NOT BE DETERMINED. ADDITIONALLY, WITHOUT AN AUTOPSY REPORT, THE CAUSE OF DEATH COULD NOT BE CONCLUSIVELY DETERMINED. THE PHYSICIAN ASSESSED THE DEATH AS UNRELATED TO THE MYNX DEVICE. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

Additional Manufacturer Narrative · 1

UPON REVIEW OF MAUDE DATABASE, IT WAS FOUND THAT THE USER FACILITY SUBMITTED A MEDWATCH REPORT # (B)(4) REPORTING THIS EVENT. THE MEDWATCH FROM THE USER FACILITY REPORTED THE EVENT DATE DIFFERENT FROM WHAT WAS ORIGINALLY REPORTED TO ACI. THIS SUPPLEMENTAL REPORT IS TO CORRECT THE DATES REPORTED ON THE ORIGINAL MEDWATCH FORM SUBMITTED BY ACI, BASED ON THE INFORMATION FROM THE MEDWATCH SUBMITTED BY THE USER FACILITY. (B)(6).

Description of Event or Problem · 1

IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A FEMALE PATIENT UNDERWENT A CORONARY RE-CATHETERIZATION PROCEDURE IN WHICH A STENT WAS IMPLANTED ON (B)(6) 2011. ACCESS WAS REPORTEDLY OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM REVEALED THE STICK TO BE AT THE "APPROPRIATE" LOCATION AND ALSO REVEALED THAT THE VESSEL WAS MODERATELY CALCIFIED. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO INFORMATION PROVIDED IN REGARDS TO THE STEPS PERFORMED IN THE DEPLOYMENT OF THE DEVICE. REPORTEDLY, A BALLOON RUPTURE OCCURRED BEFORE THE SEALANT COULD BE DELIVERED. THE DEVICE WAS REMOVED AND ACCESS WAS LOST SO THE PHYSICIAN CONVERTED THE PATIENT TO MANUAL COMPRESSION WHICH WAS HELD FOR 20 MINUTES. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS STABILIZED AND TAKEN TO THE NURSING FLOOR. IT WAS REPORTED THAT ABOUT HALF AN HOUR LATER, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO BE DROPPING AND SHE WENT INTO CARDIAC ARREST. THE PATIENT WAS ABLE TO BE RESUSCITATED SO SHE WAS BROUGHT BACK INTO THE CATH LAB FOR RECATHETERIZATION. THE PHYSICIAN ACCESSED THE ARTERY FROM THE LEFT LEG BUT THERE WAS NO ACTIVE BLEED NOTED UNDER FLUOROSCOPY. THE PATIENT'S HEMOGLOBIN HAD DROPPED TO 4 AND SHE HAD EXPIRED BEFORE SHE WAS ABLE TO BE ADEQUATELY TRANSFUSED. THE PHYSICIAN STATED THAT THE FEMORAL ANGIOGRAM OF THE PATIENT'S RIGHT COMMON FEMORAL ARTERY (RCFA) FROM THE CONTRALATERAL SIDE HAD A SOMEWHAT DIFFUSED PSEUDOANEURYSM APPEARANCE BUT THERE WAS NO ACTIVE BLEEDING AND NO FOCAL PSEUDOANEURYSM OR FLOW OBSTRUCTION. IT WAS ALSO REPORTED THAT THE PATIENT NEVER DEVELOPED A HEMATOMA. ON (B)(6) 2011, THE ACI SALES PROFESSIONAL STATED THAT THE PHYSICIAN FELT SINCE THE MYNX SEALANT WAS NOT DEPLOYED, THE DEVICE WAS NOT INVOLVED. ON (B)(6) 2011, THE ACI SALES PROFESSIONAL PROVIDED ADDITIONAL INFORMATION REPORTING THAT THE PHYSICIAN STATED THAT THE REPORTED BALLOON LOSS OF PRESSURE WAS DUE TO SIGNIFICANT CALCIFICATION OF THE COMMON FEMORAL ARTERY WHICH WAS FLUOROSCOPICALLY VISIBLE. THE PHYSICIAN STATED THAT THE PATIENT APPARENTLY HAD A LATE BLEED ABOUT 30 MINUTES AFTER ARRIVING TO THE NURSING FLOOR BUT WAS NOT ENTIRELY CLEAR THAT THE PATIENT HAD A RETROPERITONEAL BLEED (RPB). HE ALSO STATED THAT THE SUDDEN NATURE OF THE PATIENT'S HEMODYNAMIC COLLAPSE AND THE TOTALITY OF THAT COLLAPSE ARE SOMEWHAT ATYPICAL FOR RPB. THE PHYSICIAN ALSO CONFIRMED THAT THE STICK WAS NOT HIGH AND THERE WAS NO BACK WALL STICK. HE ALSO CONFIRMED THAT THE MYNX DEVICE HAD NOTHING TO DO WITH THE PATIENT'S RPB.

Description of Event or Problem · 1

IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A FEMALE PATIENT UNDERWENT A CORONARY RE-CATHETERIZATION PROCEDURE IN WHICH A STENT WAS IMPLANTED ON (B)(6) 2011. ACCESS WAS REPORTEDLY OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM REVEALED THE STICK TO BE AT THE "APPROPRIATE" LOCATION AND ALSO REVEALED THAT THE VESSEL WAS MODERATELY CALCIFIED. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO INFORMATION PROVIDED IN REGARDS TO THE STEPS PERFORMED IN THE DEPLOYMENT OF THE DEVICE. REPORTEDLY, A BALLOON RUPTURE OCCURRED BEFORE THE SEALANT COULD BE DELIVERED. THE DEVICE WAS REMOVED AND ACCESS WAS LOST SO THE PHYSICIAN CONVERTED THE PATIENT TO MANUAL COMPRESSION WHICH WAS HELD FOR 20 MINUTES. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS STABILIZED AND TAKEN TO THE NURSING FLOOR. IT WAS REPORTED THAT ABOUT HALF AN HOUR LATER, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO BE DROPPING AND SHE WENT INTO CARDIAC ARREST. THE PATIENT WAS ABLE TO BE RESUSCITATED SO SHE WAS BROUGHT BACK INTO THE CATH LAB FOR RECATHETERIZATION. THE PHYSICIAN ACCESSED THE ARTERY FROM THE LEFT LEG BUT THERE WAS NO ACTIVE BLEED NOTED UNDER FLUOROSCOPY. THE PATIENT'S HEMOGLOBIN HAD DROPPED TO 4 AND SHE HAD EXPIRED BEFORE SHE WAS ABLE TO BE ADEQUATELY TRANSFUSED. THE PHYSICIAN STATED THAT THE FEMORAL ANGIOGRAM OF THE PATIENT'S RIGHT COMMON FEMORAL ARTERY (RCFA) FROM THE CONTRALATERAL SIDE HAD A SOMEWHAT DIFFUSED PSEUDOANEURYSM APPEARANCE BUT THERE WAS NO ACTIVE BLEEDING AND NO FOCAL PSEUDOANEURYSM OR FLOW OBSTRUCTION. IT WAS ALSO REPORTED THAT THE PATIENT NEVER DEVELOPED A HEMATOMA. ON (B)(6) 2011, THE ACI SALES PROFESSIONAL STATED THAT THE PHYSICIAN FELT SINCE THE MYNX SEALANT WAS NOT DEPLOYED, THE DEVICE WAS NOT INVOLVED. ON (B)(6) 2011, THE ACI SALES PROFESSIONAL PROVIDED ADDITIONAL INFORMATION REPORTING THAT THE PHYSICIAN STATED THAT THE REPORTED BALLOON LOSS OF PRESSURE WAS DUE TO SIGNIFICANT CALCIFICATION OF THE COMMON FEMORAL ARTERY WHICH WAS FLUOROSCOPICALLY VISIBLE. THE PHYSICIAN STATED THAT THE PATIENT APPARENTLY HAD A LATE BLEED ABOUT 30 MINUTES AFTER ARRIVING TO THE NURSING FLOOR BUT WAS NOT ENTIRELY CLEAR THAT THE PATIENT HAD A RETROPERITONEAL BLEED (RPB). HE ALSO STATED THAT THE SUDDEN NATURE OF THE PATIENT'S HEMODYNAMIC COLLAPSE AND THE TOTALITY OF THAT COLLAPSE ARE SOMEWHAT ATYPICAL FOR RPB. THE PHYSICIAN ALSO CONFIRMED THAT THE STICK WAS NOT HIGH AND THERE WAS NO BACK WALL STICK. HE ALSO CONFIRMED THAT THE MYNX DEVICE HAD NOTHING TO DO WITH THE PATIENT'S RPB.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MYNX VASCULAR CLOSURE DEVICE	MGB	MGB	ACCESSCLOSURE, INC.	MX6700	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death