MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

No additional information is available for this event as the article does not provide any contact information on the author.In addition, the article did not provide information on the manufacturer of the iabp, pump model or serial number.

Event Description

The following was reported via an article reviewed by getinge: an (b)(6) year old male with a past medical history of peripheral artery disease with bilateral iliac stents, paroxysmal atrial fibrillation and ischemic cardiomyopathy presented to the emergency room with lightheadedness and palpitations.Presenting vital signs revealed a blood pressure of 144/75 mmhg, heart rate of 130 bpm and oxygen saturation 95% on room air.On physical exam he was noted to be diaphoretic and in distress.His ecg revealed ventricular tachycardia.He was treated with intravenous metoprolol tartrate, amiodarone 300 mg intravenous and subsequently required successful synchronized electrical cardioversion with 150 joules.Coronary angiogram was performed which showed triple vessel cad (90¿95% proximal rca, in-stent restenosis of mid rca with severe diffuse disease, 70¿80% mid-left anterior descending [mlad] and chronic total occlusion of left circumflex artery).Decision was made to perform pci of the mlad which was complicated by perforation requiring occlusive stent and subsequent iabp placement.During cautious attempt on removal of the iabp resistance was met due to the entrapment of the balloon to the right iliac stent (figure 3).Under fluoroscopic guidance, removal using a leftto-right femoral visualization assistance technique was used.This was complicated by thrombotic occlusion of the right distal superficial femoral artery possibly secondary tomechanical manipulation resulting in distal embolization (figure 4).Recanalization and balloon angioplasty of the lesion was successfully performed, and adequate flow was established.Hemostasis of the right groin access was achieved with manual pressure.After removal of the iabp, the right lower extremity was warm however, distal pulses could not be appreciated with doppler.Patient was maintained on aspirin, clopidogrel and heparin infusion, and planned for repeat peripheral angiography of lower extremities.Subsequently in the ccu he developed st-elevation on telemetry and ultimately expired, likely from closure of the mlad stent.

Manufacturer Narrative

Updated fields: h6 (evaluation method code).

Event Description

The following was reported via an article reviewed by getinge: an 82-year old male with a past medical history of peripheral artery disease with bilateral iliac stents, paroxysmal atrial fibrillation and ischemic cardiomyopathy presented to the emergency room with lightheadedness and palpitations.Presenting vital signs revealed a blood pressure of 144/75 mmhg, heart rate of 130 bpm and oxygen saturation 95% on room air.On physical exam he was noted to be diaphoretic and in distress.His ecg revealed ventricular tachycardia.He was treated with intravenous metoprolol tartrate, amiodarone 300 mg intravenous and subsequently required successful synchronized electrical cardioversion with 150 joules.Coronary angiogram was performed which showed triple vessel cad (90¿95% proximal rca, in-stent restenosis of mid rca with severe diffuse disease, 70¿80% mid-left anterior descending [mlad] and chronic total occlusion of left circumflex artery).Decision was made to perform pci of the mlad which was complicated by perforation requiring occlusive stent and subsequent iabp placement.During cautious attempt on removal of the iabp resistance was met due to the entrapment of the balloon to the right iliac stent (figure 3).Under fluoroscopic guidance, removal using a left to-right femoral visualization assistance technique was used.This was complicated by thrombotic occlusion of the right distal superficial femoral artery possibly secondary to mechanical manipulation resulting in distal embolization (figure 4).Recanalization and balloon angioplasty of the lesion was successfully performed, and adequate flow was established.Hemostasis of the right groin access was achieved with manual pressure.After removal of the iabp, the right lower extremity was warm however, distal pulses could not be appreciated with doppler.Patient was maintained on aspirin, clopidogrel and heparin infusion, and planned for repeat peripheral angiography of lower extremities.Subsequently in the ccu he developed st-elevation on telemetry and ultimately expired, likely from closure of the mlad stent.

• Brand Name: UNKNOWN IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10453728
• MDR Text Key: 204360872
• Report Number: 2249723-2020-01343
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN IAB; UNKNOWN IAB; UNKNOWN IAB
• Patient Outcome(s): Death
• Patient Age: 82 YR