MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-21 for GRAFTMASTER RX REF 1012580 manufactured by Abbott.
[5082635]
Add'l info received on (b)(4) 2014. The pt presented to the emergency room in a state of cardiogenic shock with pulmonary edema and had to be emergently intubated. He st elevations in anterior leads and was emergently taken to the cath lab and was found to have 100% occluded proximal lad. He had profound lv dysfunction with ef 15%. Attempts to recanalize the lad with ptca and ic adenosine were unsuccessful in establishing flow during ptca a contained perforation was noticed in the mid lad (on distal port injection). As there was no flow down the lad there were persistent contrast staining around the vessel. Attempt to pass a covered jo stent were unsuccessful given diffuse disease down the artery. A bed side echo showed no evidence of pericardial effusion. Multiple attempts to establish flow down the lad were unsuccessful (major infarct, greater than 48 hours duration) despite trying multiple approached including thrombus aspiration, ptca, balloon dottering. Ic adenosine (large doses). Final angiogram showed no flow down the lad, 100% proximal occlusion and final bed side echo (done approx an hour later still showed no pericardial effusion). The pt was then transferred to the ccu. An hour later he had a cardiac arrest and had cpr initiated with acls protocol. He had vfib and pea and required defibrillation for vfib. Several minutes into cpa a bed side echo was done which showed profound lv dysfunction and a new small effusion. Bed side pericardiocentesis was done with approx 20 cc of blood removed. Pt stayed in cardiac arrest despite cpr and acls support. The profound lv dysfunction from a massive stemi (that occurred >48 hours ago) and cardiogenic shock resulted in cardiac arrest from which the pt could not be resuscitated.
Patient Sequence No: 1, Text Type: D, B5
[5226142]
A (b)(6) woman with unk past medical history presented to ed with worsening dyspnea for 2 weeks and severe chest pain for 4 days. Pt intubated in the ed due to respiratory distress and pulmonary edema. She was noticed to have q waves v4-v6 along with st elevation and cath lab was activated. Angiomax, ebu guide, run through guidewire advanced and with moderate difficulty was able to cross the occluded segment and was parked in distal vessel, that appeared to be in diagonal. Pronto lp advanced and we performed aspiration but could not retrieve any material. We advanced a new guidewire pwf into the vessel and were able to advance it distally. It was not clear whether this vessel was lad or a septal at this stage. We then advanced pronto lp catheter and performed aspiration with no retrieval of material. We then advanced a 2x12 balloon in this vessel and performed serial dilations 10 atm with no distal flow. A 2x12 balloon then advanced over diagonal guidewire 8 atm and serial inflations performed and pt was started on versed and vecuronium drip. Pt did not require pressors throughout the case and was mildly hypotensive after initiation of sedatives and received 1 bolus of fluids. We then docked the pwf with asahi dock and advanced 1. 25x6otw, into the vessel administered adenosine through the distal port and then performed contrast injection through the balloon. This showed that this vessel is likely a septal. We then advanced the 2. 4x15 sprinter in to diagonal guidewire proximally and performed serial dilations 8 atm to establish flow distally into vessels. We then advanced a new run through guidewire into the system and advanced it. This wire appeared to track distally into the lad direction. We then docked this guidewire with doc extension and administered adenosine and then performed distal port inj. This vessel appeared to be true lad but the dye was hanging in the vessel and there was no distal flow. We then performed serial balloon inflations in the lad upto 18 atm. We then noticed there was perforation in the med vessel. Dye was hanging out in pericardium and not free flowing. We then reinflated the balloon at the site of perforation. Echocardiogram machine was brought the cath lab and images showed severe lv dysfunction ef 20 percent and no pericardial effusion. Serial fluoro images showed dye hang up around the vessel and was not free flowing. We then obtained graft master stent (from (b)(6) facility) and advanced the 2. 8x26mm covered stent over lad guidewire. Stent could not be advanced beyond the prox stenosis and was pulled back. Stent got stuck at guide tip and hence the entire guide system was pulled out of body. We then introduced a new ebu guide and engaged lm. We then introduced guidewires into lad and diagonal. Repeat angiogram showed no dye extravasation from lad. There was timi o flow at proximal lad. We then advanced 2x12 balloon in the lad and diagonal sequentially from mid vessels distally and per. We then advanced 1. 5x6 otw balloon in the diagonal and administered multiple rounds of adenosine down the lad and d; but there was no reflow (timi 0). We then removed all the 3 guidewires and final angiogram showed no distal flow in lad or diagonal. After doing multiple attempts and all maneuvers and unable to establish distal flow we decided to conclude. We performed long cine imaging and confirmed there was no dye extravasation. Final echo images confirmed no pericardial effusion and case was concluded. Pt's hemodynamics were stable with blood pressure 133/80 at the case conclusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039280 |
| MDR Report Key | 4284281 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-14 |
| Date Added to Maude | 2014-12-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER RX |
| Generic Name | GRAFTMASTER RX STENT |
| Product Code | NIV |
| Date Received | 2014-11-21 |
| Model Number | REF 1012580 |
| Lot Number | 311214A |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | SANTA CLARA 95054 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-11-21 |